Páginas Extraídas de 4. E.T EXCIPIENTES-Amoxicillin Capsules 500mg - Traducir

ZHONGSHAN LEAN&LEAP PHARMACEUTICAL CO., LTD.
Address: No.28,Huaye Road,Yongning District, Xiaolan Town, Zhongshan City, Guangdong

Province, China
Amoxicillin capsules 500mg
TECHNICAL SPECIFICATIONS OF EXCIPIENTS
Product name: Sodium starch glycolate (type A) reference: BP2024

Tests Specification
Appearance White or almost white, fine, free-flowing powder, very hygroscopic.
Practically insoluble in methylene chloride. It gives a translucent
Solubility
suspension in water.
A: pH: 5.5-7.5.
B: A suspension forms that settles after standing.
C: The solution becomes blue or violet.
D: Solution S2 gives reaction (a) of sodium: Add 2 ml of a 150 g/l
Identification
solution of potassium carbonate R and heat to boiling. No precipitate is
formed. Add 4 ml of potassium pyroantimonate solution R and heat to
boiling. Allow to cool in iced water and if necessary rub the inside of the
test-tube with a glass rod. A dense white precipitate is formed.
Appearance of solution Solution S1 is clear and colourless
pH 5.5 to 7.5
Sodium glycolate Not more than 2.0%
Sodium chloride Not more than 7.0%
Iron Not more than 20ppm
Loss on drying Not more than 10.0%
Microbial Escherichia coli: Absent/g
contamination Salmonella: Absent/10g
Assay 2.8%-4.2%
Signature: Signature:
Name: Hu Shuyun Name: Zhong Jinying
Position: QC manager Position: QA manager
Province, China
Product name: Magnesium stearate reference: BP2024
Tests Specification
Appearance White or almost white, very fine, light powder, greasy to the touch.
Solubility Practically insoluble in water and in anhydrous ethanol.
A: Freezing point: minimum 53℃, determined on the residue obtained in the
preparation of solution S.
B: Acid value (2.5.1): 195 to 210.
Identification C: The 2 principal peaks in the chromatogram obtained with the test solution
are similar in retention time to the 2 principal peaks in the chromatogram
obtained with the reference solution.
D. A white crystalline precipitate is formed.
Not more than 0.05 M hydrochloric acid or 0.1 M sodium hydroide is
Acidity or alkalinity
required to change the colour of indicator.
Chloride Not more than 0.10%
Sulfates Not more than 1.0%
Cadmium Not more than 3ppm
Lead Not more than 10ppm
Nickel Not more than 5ppm
Loss on drying Not more than 6.0%
Total Aerobic microbial count: Not more than 103cfu/g
Microbial Total combined yeasts and molds count: Not more than 102cfu/g
contamination Escherichia coli: Absent/g
Salmonella: Absent/10g
Magnesium: 4.0% to 5.0 % (dried substance)
Assay Stearic acid in the fatty acid fraction: ≥40.0 %
Sum of stearic acid and palmitic acid in the fatty acid fraction: ≥90.0%
Province, China
Product name: Vacant Gelatin Capsules reference: In-house
Tests Specification
Characteristic Cylindrical. hard, elastic empty capsules, which consist of
telescoping cap and body pieces. Capsules should have a clean,
smooth and uniformly coloured surface, odourless, well trimmed
and shaped without deformation
0# capsule-brownish red (cap) and yellow (body)
Identification (1)Produce orange flocculent precipitate
(2)An opalescence is produced.
(3)The gas generated turns the moistened red litmus TP blue.
Compactness No more than 1 capsule leaking powder
Friability No more than 5 capsules ruptured
Disintegration Not more than 10min
Viscosity The kinematic viscosity is not less than 60mm2/s.
Sulfite Not more than 0.01%
Ethylene chlorohydrin The area of any peak due to ethylene chlorohydrin in the
chromatogram obtained with the test solution is not greater than
that of the principal peak obtained with the reference solution
Oxane Not more than 0.0001%
Loss on drying 12.5% to 17.5%
Residue on ignition Not more than 5.0%
Chromium Not more than 0.0002%
Heavy metals Not more than 0.004%
Microbial limit Total aerobic microbial count: not more than 1000cfu/g
Total combined yeasts and molds count: not more than 100cfu/g
Escherichia coli: absent/g
Salmonella: absent/10g
Province, China
ANALYTICAL METHODOLOGY OF EXCIPIENTS

Product name: Sodium starch glycolate (type A) reference: BP2024
DEFINITION
Sodium salt of a cross-linked partly O-carboxymethylated potato starch.
Content
2.8 per cent to 4.2 per cent of Na (Ar 22.99) (substance washed with ethanol (80 per cent V/V) and
dried).
CHARACTERS
Appearance
White or almost white, fine, free-flowing powder, very hygroscopic.
Solubility
Practically insoluble in methylene chloride. It gives a translucent suspension in water.
IDENTIFICATION
A. pH (see Tests).
B. Prepare with shaking and without heating a mixture of 4.0 g of the substance to be examined and
20mL of carbon dioxide-free water R. The mixture has the appearance of a gel. Add 100mL of
carbon dioxide-free water R and shake. A suspension forms that settles after standing.
C. To an acidified solution, add iodinated potassium iodide solution R1. The solution becomes blue
or violet.
D. Solution S2 (see Tests) gives reaction (a) of sodium (2.3.1).
TESTS
Solution S1
Centrifuge the suspension obtained in identification test B at 2500 g for 10 min. Collect carefully the
supernatant liquid.
Solution S2
Place 2.5g in a silica or platinum crucible and add 2mL of a 500 g/L solution of sulfuric acid R. Heat
on a water-bath, then cautiously over a naked flame, raising the temperature progressively, then
incinerate in a muffle furnace at 600±25℃. Continue heating until all black particles have
disappeared. Allow to cool, add a few drops of dilute sulfuric acid R, heat and incinerate as above.
Allow to cool, add a few drops of ammonium carbonate solution R, evaporate to dryness and
incinerate cautiously. Allow to cool and dissolve the residue in 50mL of water R.
Appearance of solution S1
Solution S1 is clear (2.2.1) and colourless (2.2.2, Method II).
pH (2.2.3)
5.5 to 7.5.
Disperse 1.0 g in 30 mL of carbon dioxide-free water R.
Sodium glycolate
Maximum 2.0 per cent. Carry out the test protected from light.
Test solution: Place 0.20 g in a beaker. Add 5mL of acetic acid R and 5mL of water R. Stir until
dissolution is complete (about 10 min). Add 50mL of acetone R and 1 g of sodium chloride R. Filter
through a fast filter paper impregnated with acetone R, rinse the beaker and filter with acetone R.
Combine the filtrate and washings and dilute to 100.0mL with acetone R. Allow to stand for 24 h
without shaking. Use the clear supernatant liquid.
Province, China
Reference solution: Dissolve 0.310 g of glycolic acid R, previously dried in a desiccator (2.2.32) at
room temperature overnight, in water R and dilute to 500.0 mL with the same solvent. To 5.0 mL of
this solution add 5 mL of acetic acid R and allow to stand for about 30 min. Add 50 mL of acetone R
and 1 g of sodium chloride R. Filter through a fast filter paper impregnated with acetone R, rinse the
beaker and filter with acetone R. Combine the filtrate and washings and dilute to 100.0 mL with
acetone R. Allow to stand for 24 h without shaking. Use the clear supernatant.
Heat 2.0mL of the test solution on a water-bath for 20 min. Cool to room temperature and add
20.0mL of 2,7-dihydroxynaphthalene solution R. Shake and heat in a water-bath for 20 min. Cool
under running water, transfer to a volumetric flask and dilute to 25.0mL with sulfuric acid R,
maintaining the flask under running water. Within 10 min, measure the absorbance at 540nm (2.2.25)
using water R as the compensation liquid. The absorbance of the solution prepared with the test
solution is not greater than that of a solution prepared at the same time and in the same manner with
2.0mL of the reference solution.
Sodium chloride
Maximum 7.0 per cent.
Place 0.500 g in a beaker and suspend in 100 mL of water R. Add 1 mL of nitric acid R. Titrate with
0.1 M silver nitrate, determining the end-point potentiometrically (2.2.20), using a silver-based
indicator electrode and a double-junction reference electrode containing a 100 g/L solution of
potassium nitrate R in the outer jacket and a standard filling solution in the inner jacket.
1mL of 0.1 M silver nitrate is equivalent to 5.844 mg of NaCl.
Iron (2.4.9)
Maximum 20 ppm determined on 10mL of solution S2.
Loss on drying (2.2.32)
Maximum 10.0 per cent, determined on 1.000g by drying in an oven at 130 ℃ for 1.5h.
Microbial contamination
It complies with the test for Escherichia coli and Salmonella (2.6.13).
ASSAY
Shake 1.000 g with 20mL of ethanol (80 per cent V/V) R, stir for 10 min and filter. Repeat the
operation until chloride has been completely extracted and verify the absence of chloride using silver
nitrate solution R2. Dry the residue at 105 ℃ to constant mass. To 0.700 g of the dried residue, add
80mL of glacial acetic acid R and heat under a reflux condenser for 2h. Cool the solution to room
temperature. Titrate with 0.1M perchloric acid, determining the end-point potentiometrically (2.2.20).
Carry out a blank titration.
1mL of 0.1 M perchloric acid is equivalent to 2.299 mg of Na.
Province, China
Product name: Magnesium stearate reference: BP2024

DEFINITION
Compound of magnesium with a mixture of solid organic acids and consisting mainly of variable
proportions of magnesium stearate and magnesium palmitate obtained from sources of vegetable or
animal origin.
Content:
-magnesium (Mg; Ar 24.305): 4.0 per cent to 5.0 per cent (dried substance);
-stearic acid in the fatty acid fraction: minimum 40.0 per cent;
- sum of stearic acid and palmitic acid in the fatty acid fraction: minimum 90.0 per cent.
CHARACTERS
Appearance
White or almost white, very fine, light powder, greasy to the touch.
Solubility
Practically insoluble in water and in anhydrous ethanol.
IDENTIFICATION
First identification C, D.
Second identification A, B, D.
A. Freezing point (2.2.18): minimum 53 ℃, determined on the residue obtained in the preparation of
solution S (see Tests).
B. Acid value (2.5.1): 195 to 210.
Dissolve 0.200 g of the residue obtained in the preparation of solution S in 25mL of the prescribed
mixture of solvents.
C. Examine the chromatograms obtained in the assay of stearic acid and palmitic acid.
Results The 2 principal peaks in the chromatogram obtained with the test solution are similar in
retention time to the 2 principal peaks in the chromatogram obtained with the reference solution.
D. To 1mL of solution S add 1mL of dilute ammonia R1; a white precipitate is formed that dissolves
on addition of 1mL of ammonium chloride solution R. Add 1mL of a 120 g/L solution of disodium
hydrogen phosphate R; a white crystalline precipitate is formed.
TESTS
Solution S
To 5.0 g add 50mL of peroxide-free ether R, 20mL of dilute nitric acid R and 20mL of water R and
heat under a reflux condenser until dissolution is complete. Allow to cool. In a separating funnel,
separate the aqueous layer and shake the ether layer with 2 quantities, each of 4mL, of water R.
Combine the aqueous layers, wash with 15mL of peroxide-free ether R and dilute to 50.0mL with
water R (solution S). Evaporate the organic layer to dryness and dry the residue at 100-105 ℃. Keep
the residue for identification tests A and B.
Acidity or alkalinity
To 1.0 g add 20mL of carbon dioxide-free water R and boil for 1 min with continuous shaking. Cool
and filter. To 10mL of the filtrate add 0.05mL of bromothymol blue solution R4. Not more than
0.05mL of 0.1M hydrochloric acid or 0.1M sodium hydroxide is required to change the colour of the
indicator.
Chlorides
Province, China
Dilute 10.0mL of solution S to 40mL with water R. Neutralise if necessary with nitric acid R using
litmus R as indicator. Add 1mL of nitric acid R and 1mL of 0.1 M silver nitrate and dilute to 50mL
with water R. Mix and allow to stand for 5 min protected from light. The turbidity, if any, is not
greater than that produced in a solution containing 1.4mL of 0.02 M hydrochloric acid .
Sulfates
Dilute 6.0mL of solution S to 40mL with water R. Neutralise if necessary with hydrochloric acid R
using litmus R as indicator. Add 1mL of 3 M hydrochloric acid and 3mL of a 120 g/L solution of
barium chloride R and dilute to 50mL with water R. Mix and allow to stand for 10 min. The turbidity,
if any, is not greater than that produced in a solution containing 3.0mL of 0.02 M sulfuric acid .
Cadmium
Maximum 3 ppm.
Atomic absorption spectrometry (2.2.23, Method II).
For the preparation of all aqueous solutions and for the rinsing of glassware before use, employ
water that has been passed through astrong-acid, strong-base, mixed-bed ion-exchange resin before
use. Select all reagents to have as low a content of cadmium, lead andnickel as practicable and store
all reagent solutions in containers of borosilicate glass. Clean glassware before use by soaking in a
warm 773 g/L solution of nitric acid R for 30 min and by rinsing with deionised water.
Blank solution: Dilute 25 mL of cadmium- and lead-free nitric acid R to 100.0 mL with water R.
Modifier solution Dissolve 20 g of ammonium dihydrogen phosphate R and 1 g of magnesium
nitrate R in water R and dilute to 100 mL with the same solvent. Alternatively, use an appropriate
matrix modifier as recommended by the graphite furnace atomicabsorption (GFAA) spectrometer
manufacturer.
Test solution: Place 0.100 g of the substance to be examined in a polytetrafluoroethylene digestion
bomb and add 2.5 mL of cadmium- and lead-free nitric acid R. Close and seal the bomb according to
the manufacturer's operating instructions (when using a digestion bomb, be thoroughly familiar with
the safety and operating instructions. Carefully follow the bomb manufacturer's instructions
regarding care and maintenance of these digestion bombs. Do not use metal jacketed bombs or liners
which have been used with hydrochloric acid due to contamination from corrosion of the metal
jacket by hydrochloric acid). Heat the bomb in an oven at 170 °C for 3 h. Cool the bomb slowly in
air to room temperature according to the bomb manufacturer's instructions. Place the bomb in a fume
cupboard and open carefully as corrosive gases may be expelled. Dissolve the residue in water R and
dilute to 10.0 mL with the same solvent.
Reference solution: Prepare a solution of 0.0030 μg/mL of Cd by suitable dilutions of a 0.00825
μg/mL solution of cadmium nitrate tetrahydrate R in the blank solution.
Dilute 1.0 mL of the test solution to 10.0 mL with the blank solution. Prepare mixtures of this
solution, the reference solution and the blank solution in the following proportions: (1.0:0:1.0
V/V/V), (1.0:0.5:0.5 V/V/V), (1.0:1.0:0 V/V/V). To each mixture add 50 μL of modifier solution and
mix. These solutions contain respectively 0 μg, 0.00075 μg and 0.0015 μg of cadmium per millilitre
from the reference solution (keep the remaining test solution for use in the test for lead and nickel).
Source Cadmium hollow-cathode lamp.
Wavelength: 228.8 nm.
Atomisation device Furnace.
Province, China
Platform Pyrolytically coated with integrated tube.

Operating conditions Use the temperature programme recommended for cadmium by the GFAA
spectrometer manufacturer. An example of temperature parameters for GFAA analysis of cadmium
is shown below.
Lead
Maximum 10 ppm.
water that has been passed through a strong-acid, strong-base, mixed-bed ion-exchange resin before
use. Select all reagents to have as low a content of cadmium, lead and nickel as practicable and store
Blank solution: Use the solution described in the test for cadmium.
Modifier solution: Use the solution described in the test for cadmium.
Test solution: Use the solution described in the test for cadmium.
Reference solution: Prepare a solution of 0.100 μg/mL of Pb by suitable dilutions of lead standard
solution (100 ppm Pb) R with the blank solution.
Prepare mixtures of the test solution, the reference solution and the blank solution in the following
proportions: (1.0:0:1.0 V/V/V), (1.0:0.5:0.5 V/V/V), (1.0:1.0:0 V/V/V). To each mixture add 50 μL
of modifier solution and mix. These solutions contain respectively 0 μg, 0.025 μg and 0.05 μg of lead
per millilitre from the reference solution.
Source Lead hollow-cathode lamp.
Wavelength 283.3 nm.
Operating conditions Use the temperature programme recommended for lead by the GFAA
spectrometer manufacturer. An example of temperature parameters for GFAA analysis of lead is
shown below
Nickel
Maximum 5 ppm.
water that has been passed through a strong-acid, strong-base, mixed-bed ion-exchange resin before
Province, China
use. Select all reagents to have as low a content of cadmium, lead and nickel as practicable and store
Blank solution: Use the solution described in the test for cadmium.
Modifier solution: Dissolve 20 g of ammonium dihydrogen phosphate R in water R and dilute to 100
mL with the same solvent.
Alternatively, use an appropriate matrix modifier as recommended by the GFAA spectrometer
manufacturer.
Test solution: Use the solution described in the test for cadmium.
Reference solution: Prepare a solution of 0.050 μg/mL of Ni by suitable dilutions of a 0.2477 μg/mL
solution of nickel nitrate hexahydrate R in the blank solution.
Prepare mixtures of the test solution, the reference solution and the blank solution in the following
proportions: (1.0:0:1.0 V/V/V), (1.0:0.5:0.5 V/V/V), (1.0:1.0:0 V/V/V). To each mixture add 50 μL
of matrix modifier solution and mix. These reference solutions contain respectively 0 μg, 0.0125 μg
and 0.025 μg of nickel per millilitre from the reference solution.
Source Nickel hollow-cathode lamp.
Wavelength 232.0 nm.
Operating conditions Use the temperature programme recommended for nickel by the GFAA
spectrometer manufacturer. An example of temperature parameters for GFAA analysis of nickel is
shown below.
Loss on drying (2.2.32)
Maximum 6.0 per cent, determined on 1.000 g by drying in an oven at 105 ℃.
Microbial contamination.
TAMC: acceptance criterion 103 CFU/g (2.6.12).
TYMC: acceptance criterion 102 CFU/g (2.6.12).
Absence of Escherichia coli (2.6.13).
Absence of Salmonella (2.6.13).
ASSAY
Magnesium
To 0.500 g in a 250mL conical flask add 50mL of a mixture of equal volumes of anhydrous ethanol
R and butanol R, 5mL of concentrated ammonia R, 3mL of ammonium chloride buffer solution pH
10.0 R, 30.0mL of 0.1 M sodium edetate and 15 mg of mordant black 11 triturate R. Heat at 45-50
℃ until the solution is clear and titrate with 0.1 M zinc sulfate until the colour changes from blue
to violet. Carry out a blank titration.
1mL of 0.1 M sodium edetate is equivalent to 2.431 mg of Mg.
Stearic acid and palmitic acid
Gas chromatography (2.2.28): use the normalisation procedure.
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Test solution: In a conical flask fitted with a reflux condenser, dissolve 0.10 g of the substance to be
examined in 5mL of boron trifluoride-methanol solution R. Boil under a reflux condenser for 10 min.
Add 4mL of heptane R through the condenser and boil again under a reflux condenser for 10 min.
Allow to cool. Add 20mL of saturated sodium chloride solution R. Shake and allow the layers to
separate. Dry the organic layer over 0.1 g of anhydrous sodium sulfate R (previously washed with
heptane R). Dilute 1.0mL of the solution to 10.0mL with heptane R.
Reference solution: Prepare the reference solution in the same manner as the test solution using 50.0
mg of palmitic acid CRS and 50.0 mg of stearic acid CRS instead of the substance to be examined.
Column:
- material: fused silica;
-size: l = 30 m, Ø= 0.32 mm;
- stationary phase: macrogol 20 000 R (film thickness 0.5ul).
Carrier gas: helium for chromatography R.
Flow rate: 2.4mL/min.
Temperature:
Detection: Flame ionisation.

Injection: 1ul.
Relative retention: With reference to methyl stearate: methyl palmitate = about 0.9.
System suitability: Reference solution:
- resolution: minimum 5.0 between the peaks due to methyl palmitate and methyl stearate;
- relative standard deviation: maximum 3.0 per cent for the areas of the peaks due to methyl
palmitate and methyl stearate, determined on 6 injections; maximum 1.0 per cent for the ratio of
the areas of the peaks due to methyl palmitate to the areas of the peaks due to methyl stearate,
determined on 6 injections.
Province, China
Product name: Vacant Gelatin Capsules reference: In-house
Vacant gelatin capsules are made of gelatin for capsules with excipients.
Description
Cylindrical, hard, elastic empty capsules, which consist of telescoping cap and body pieces. Capsules
should have a clean, smooth and uniformly coloured surface, odourless, well trimmed and shaped
without deformation. 0# capsule-brownish red (cap) and yellow (body).
Identification
(1) Dissolve 0.25 g in 50 ml of water by heating, cool and shake thoroughly. To 5 ml of the solution
add a few drops of a mixture of potassium dichromate TS and dilute hydrochloric acid (4:1), an
orange flocculent precipitate is formed.
(2) T o 1 ml of the solution obtained in test (1) for Identification, add 50 ml of water, mix well and
add a few drops of tannic acid TS. An opalescence is produced.
(3) Place 0.3 g in a test tube, add a quantity of soda lime and heat. The gas generated turns the
moistened red litmus TP blue.
Compactness
Take 10 capsules, press gently at the ends of cap and body with thumb and forefinger, rotatively
open, and no adhesion, deformation o r breakage occurred. Fill the bodies with talc, join and lock the
capsules, drop each filled capsule separately from a height of 1 metre to a wooden plate 2 cm thick.
No powder leakage or not more than 1 capsule slightly leaked. If more than 1 capsule fail, repeat the
test with another 1 0, comply with the requirements.
Friability
Place 50 capsules in a culture dish, and move into a desiccator with saturated magnesium nitrate
solution, allow to stand at 25°C±1°C for 24 hours. Remove and immediately put individual capsule
into the glass tube (24mm in inner diameter and 200 mm long), vertically placed on the wooden plate
(20 mm thick) . Free-drop a cylindric balance weight (it is made from polytetrafluoroethylene, 22mm
in diameter, and weighs 20±0.1g ) on the capsule from the top of the glass tube. Not more than 5
capsules broken.
Disintegration
Fill 6 capsules with talc, carry out the test for disintegration. All 6 capsules should disintegrate with
in 10 minutes. If 1 capsule fails, repeat the test with an other 6 capsules. All capsules should comply
with the test.
Viscosity
Place 4.50 g in a 100 ml beaker previously weighed accurately, add 20 ml of warm water and heat in
a water bath at 60°C, with gentle stir to dissolve. Remove the beaker from the bath and quickly wipe
the water from exterior. Add water to the gel-solution to the total weight required in the following
formula (containing 15.0% of dry substance). Place the homogeneous solution into a dry conical
flask with stopper, tightly close and allow to stand in the water bath at 40°C±0.1°C for about 10
minutes. Transfer the solution to Ostwald-type Viscosimeter, carry out the test for determination of
viscosity ( using the capillary tube with 2.0 mm of the internal diameter) in the water bath at
40°C±0.1°C. The kinematic viscosity is not less than 60 mm2/s.
Total weight of gel-solution (g)
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Sulfite (calculated as SO2)

Soak 5.0 g in a long neck round bottomed flask in 100 ml of hot water and allow to swell. Add 2 ml
of phosphoric acid and 0.5 g of sodium bicarbonate, and connect the flask with a condenser
immediately. Distill and collect 50 ml of the distillate under the surface of 15 ml of 0.05 mol/L
iodine solution. Dilute the solution to 100 ml with water. Mix well and transfer 50ml to evaporate on
a water bath , add a volume of water timely and continue to evaporate until the liquid is nearly
colourless. Dilute the solution to 40 ml with water, carry out the limit test for sulfates. Any
opalescence produced is not more pronounced than that of a reference solution using 3.75 ml of
potassium sulfate standard solution (0.01%)
Ethylene chlorohydrin
Cut capsules to pieces, accurately weigh 2.5 g, place in a conical flask with a stopper, add 25 ml of
n-hexane, soak overnight. Transfer to a separator, add 2 ml of water accurately, shake and allow it to
separate. Use aqueous layer as test solution. Weigh accurately a quantity of ethylene chlorohydrin ,
dissolve in and dilute with n-hexane to produce a solution containing 22ug per ml, transfer accurately
2 ml ethylene chlorohydrin solution to a separator containing 24 ml of n-hexane, add 2 ml of water
accurately and extract, use aqueons layer as reference solution. Carry out the method for gas
chromatography, using a capillary column bounded with 10% polyethylene glycol, maintaining the
temperature of the column at 110°C. Th e area of any peak due to ethylene chlorohydrin in the
chromatogram obtained with the test solution is not greater than that of the principal peak obtained
with the reference solution.
Oxane
Accurately weigh 2.0 g of capsules, place in a 20 ml headspace vial, accurately add 10 ml of water at
60°C, seal and shake to dissolve as test solution. Place about 60 ml of water in a 100 ml volumetric
flask with dry exterior and stopper, weigh accurately. Inject 0.3 ml of oxane, shake with no stopper,
add stopper and weigh accurately. The difference between the weights is the weight of oxane in the
solution. Transfer accurately a quantity of the solution, dilute with water to produce a solution
containing 2ug per ml as reference solution. Transfer accurately 1 ml of reference solution into a 20
ml headspace vial, accurately add 9 ml of water. Carry out the test for residual solvents. Use a
column packed with 5% methylpolysiloxane or polyethylene glycol (or stationary phase with similar
polarity ). Maintain the temperature of the column at 45°C and equilibrate headspace vial for 15
minutes at 80°C. T h e area of any peak due to oxane in the chromatogram obtained with the test
solution is not greater than that of the principal peak obtained with the reference solution (0.0001% ).
(This item is tested for the products sterilized by oxane method ).
Loss on drying
Weigh accurately 1.0 g , separate the body and cap, when dried at 105°C for 6 hours, loses 12.5% -
17.5% of its weight.
Residual on ignition
Not more than 2.0% (transparent), 3.0% (half transparent), 5.0% (opaque), using 1.0 g.
Chromium
Place 0.5 g in a PTFE vessel, add 5-10 ml of nitric acid, shake thoroughly, allow to stand overnight.
Province, China
Stopper and allow to digest in a microwave digestion system. After digestion has been completed,
evaporate the solution on the electric heating plate until reddish-brown fumes are no longer evolved
and near to dryness by gently heating. Transfer to a 50 ml volumetric flask with 2% nitric acid, and
dilute to volume as test solution. Perform a blank test omitting the substance being examined. Use
the solution obtained as blank solution. Transfer accurately a quantity of chromium standard solution,
dilute with 2% nitric acid solution to produce a solution of 1.0ug per ml as chromium standard stock
solution. Before determination, transfer accurately a quantity of chromium standard stock solution,
dilute with 2% nitric acid solution to produce a successive solutions of 0-80ng per ml as chromium
reference solutions. Carry out the method for atomic absorbance spectrophotometry, measure the
absorbances of reference solutions and test solution at 357.9nm. Calculate the content of chromium:
not more than 0.0002%.
Heavy metal
Carry out the limit test for heavy metal, using the residue obtained in the test for Residual on ignition:
not more than 0.004%.
Microbial limit
Carry out the test for microbial limit, the number of bacterial is no t more than 1000cfu and that of
fungus and yeast is not more than 100cfu, and Escherichia coli is absent per g of the substance
being examined, and Salmonella is absent per 10 g of the substance being examined.

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ZHONGSHAN LEAN&LEAP PHARMACEUTICAL CO., LTD.

Address: No.28,Huaye Road,Yongning District, Xiaolan Town, Zhongshan City, Guangdong

TECHNICAL SPECIFICATIONS OF EXCIPIENTS

Product name: Sodium starch glycolate (type A) reference: BP2024

Product name: Magnesium stearate reference: BP2024

Product name: Vacant Gelatin Capsules reference: In-house

ANALYTICAL METHODOLOGY OF EXCIPIENTS

Product name: Magnesium stearate reference: BP2024

Platform Pyrolytically coated with integrated tube.

Detection: Flame ionisation.

Product name: Vacant Gelatin Capsules reference: In-house

Sulfite (calculated as SO2)

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