YASH PHARMA LABORATORIES PVT.

LTD
Khasra No.19M, Village: Raipur, Pargana: Bhagwanpur,Tehsil– Roorkee,
Distt: - Haridwar, Uttarakhand

Department Quality control Document Type Standard testing procedure

Material Name Colour erythrosine supra Page No. Page 1 of 3
STP No. YPR/STP/RM/134 Pharm. Ref. IHS
Effective From Document validity

1. Description: A pink coloured powder.

2. Solubility: Freely soluble in water and in dilute acids & in dilute alkali.

3. Identification:
A By Assay: The final solution obtained in the assay gives maximum absorbance at 428 nm.

4. pH :Weight 1.0 g of the sample in 100 ml volumetric flask and dissolve in water produce the 100 ml
with water and check the pH of these solutions.Limit:5.00 to 8.50

5. Heavy metals:
Standard solution: Into a 50 ml Nessler Cylinder pipette 1.0 ml of Lead Standard solution (40 ppm
pb) and dilute with water to 25 ml. Adjust with dilute Acetic Acid or dilute Ammonia solution to a
pH between 3.0 and 4.0 dilute with water to about 35 ml and mix.

Test solution: Weigh 1.0 g in a suitable crucible, add sufficient Sulphuric Acid to wet the sample,
ignite carefully at a low temperature until thoroughly charred. Add to the charred mass 2 ml of Nitric
Acid and 5 drops of Sulphuric Acid and heat cautiously until white fumes are no longer evolved.
Ignite, preferably in a muffle furnace, at 500° to 600°C, until the carbon is completely burnt off.
Cool, add 4 ml of Hydrochloric Acid, cover, digest on a water-bath for 15 minutes, uncover and
slowly evaporate to dryness on a water-bath. Moisten the residue with 1 drop of Hydrochloric Acid,
add 10 ml of hot water and digest for 2 minutes.
Add Ammonia solution to dropwise until the solution is just alkaline to litmus paper, dilute to 25 ml
with water and adjust with dilute Acetic Acid to a pH between 3.0 and 4.0. filter, if necessary,
rinse the crucible and the filter with 10 ml of water, combine the filtrate and washings in a 50 ml
Nessler Cylinder, dilute with water to about 35 ml and mix.

Procedure:
To each of the cylinders containing the standard solution and test solution respectively add 10 ml of
freshly prepared Hydrogen Sulphide solution. Mix, dilute to 50 ml with water, allow standing for 5
minutes and viewing downwards over a white surface; the colour produced with the test solution is
not more intense than that produced with the standard solution.
Limit: Not more than :40ppm.

Prepared by Checked by Approved by

Name
Designation
Sign. & Date
Format No :YPR/QC/081/F02-00
 YASH PHARMA LABORATORIES PVT.LTD
Khasra No.19M, Village: Raipur, Pargana: Bhagwanpur,Tehsil– Roorkee,
Distt: - Haridwar, Uttarakhand

Department Quality control Document Type Standard testing procedure

Material Name Colour erythrosine supra Page No. Page 2 of 3
STP No. YPR/STP/RM/134 Pharm. Ref. IHS
Effective From Document validity

6. Arsenic: Dissolve 5.0 g. in 10 ml of Bromine solution and evaporate to dryness on a water – bath.
Ignite gently, dissolve the cooled residue, ignoring any carbon, in 50 ml of water and 14 ml of
Brominated Hydrochloric Acid AsT and remove the excess of bromine with a few drops of Stannous
Chloride solution AsT.
Into the bottle or conical flask introduce the test solution prepared as directed above; add 5 ml of 1 M
Potassium Iodide and 10 g of Zinc AsT. Immediately assemble the apparatus and immerse the flask
in a water-bath at the temperature such that a uniform evolution of gas is maintained. After 40
minutes any stain produced on the Mercuric Chloride paper is not more intense than that obtained by
treating in the same manner 1 ml of Arsenic Standard solution (10 ppm As) diluted to 50 ml with
water.
Limit: Not more than 3 PPM
7. Water Insoluble Matter: Weigh accurately about 2 g of sample and shake with 100 ml of distilled
water for 5 minutes and filter through sintered glass crucible G4 (previously dried & weighed). Dry
the crucible at 105oC to the constant weight and find out the weight of insoluble matter.

Calculation:
Weight of Insoluble matter
% of Insoluble matter = --------------------------------------- X 100
Weight of sample

=……………………….%

Limit :Not more than :Not more than 0.5%

8. Loss on drying:
Place the 1 g of the substance to be examined in a weighing bottle previously dried under the
conditions. Dry the substance for the 2 hours in 1100C.after drying the sample cooled in desiccators
and weighing the bottle.
Weight of weighing bottle = ____________g (A)
Weight of weighing bottle + sample = ____________g (B)
Weight of sample (B-A) = ____________g (C)
Weight of weighing bottle + sample = ___________g (D) (After drying at110 oC. for 2hrs)
Loss in weight (B-D) = ________________g (E)

(E)

Prepared by Checked by Approved by

Name
Designation
Sign. & Date
Format No :YPR/QC/081/F02-00
 YASH PHARMA LABORATORIES PVT.LTD
Khasra No.19M, Village: Raipur, Pargana: Bhagwanpur,Tehsil– Roorkee,
Distt: - Haridwar, Uttarakhand

Department Quality control Document Type Standard testing procedure

Material Name Colour erythrosine supra Page No. Page 3 of 3
STP No. YPR/STP/RM/134 Pharm. Ref. IHS
Effective From Document validity

Loss on drying -------------------------- X100 = _________________%

(C

Limit:Not more than 20.0%

9. Total dye content: Weigh accurately about 100 mg of the sample and transfer into 200 ml
volumetric flask. Add 20 ml of Water and dissolve. Make up the volume with same water. Dilute
2.0 ml to 100.0 ml ml with same solvent. Read the absorbance of final solution at 527 nm using
water as blank. Calculate the assay taking value of A1% 1080

Calculation:
Abs. 200 100 1
% Dye Content = ------ X -------------------- X --------- X --------- X 100
520 Wt of sample (g) 2 100

Limit: Not less than 85.0%

Prepared by Checked by Approved by

Name
Designation
Sign. & Date
Format No :YPR/QC/081/F02-00