Product Testing Parameter Compendial

Reducing Sugar EP
Reducing Sugar after Hydrol EP
Sorbitol
Assay EP
Water EP
Chloride EP
Sulphates EP
Iron EP
Loss on ignition EP
Assay (as SIO2) EP

Silica 153 Specific surface area EP

Sieve Test C-5012_7.1

Oil Absorption SCM604
Flouride Compatability C-5089
Lead
FCC
(For US market only)
Chloride EP
Sulphates EP
Iron EP
Loss on ignition EP
Assay (as SIO2) EP

Specific surface area EP

Silica 113
Sodium Sulphate Supplier C of A
Sieve Test C-5012_7.1
Oil Absorption SCM604
Flouride Compatability C-5089
Lead
FCC
(For US market only)

Identification JSFA
Clarity and color of solution JSFA
Potassium Nitrate Chloride JSFA
Lead JSFA
Arsenic JSFA
Assay JSFA
Identification 2 - Active M SCM609
Tego Betaine Sodium chloride C-6201
Amidoamine / Amid Ammo C-5862
Assay USP-NF

Xanthan Gum
 Arsenic (As) USP-NF
Lead (Pb) USP-NF
Xanthan Gum Limit of isopropyl Alcohol USP-NF
Pyruvic Acid USP-NF
Ash USP-NF
Particle Size -Sieve C-5012_7.1
o- and p-
EP
Toluenesulfonamide
Readily carbonisable
EP
substances
Sodium Saccharine
Water
EP
(0.200 g sample)

Assay EP

Total Esters USP

Peppermint Oil Total Menthol USP

Limit of Dimethyl Sulfide USP

Chlorides EP
Sodium Fluoride
Sulfates EP
Carbonates EP
Chlorides EP
Sodium Hydroxide
Sulfates EP
Iron EP
Assay USP
Residu on Ignition USP
Limit of Methanol USP

Related Compound USP

Sucralose

Limit of Hydrolysis Product USP

Water Determination USP

Arsenic 400-0017
Zinc Citrate Lead 400-2414
Cadmium 400-2414
Water Soluble substances EP 9.0
Antimony EP 9.0
Arsenic EP 9.0
Titanium Oxide
Titanium Oxide
Barium EP 9.0
Iron EP 9.0
Assay EP 9.0
Assay USP

Chromatography USP

L-Menthol
Related substance (GC) USP

Residue on evaporation/
Limit of nonvolatile USP
residue
Residual Solvent USP

Methyl Salicylate Related Substances EP

C-5150 and
GC assay and
C-5150
identification
(U0232)
Spearmint Oil
USP or
Carvone content BP2002
(605147)
Arsenic FCC
STPP Anhydrous Fluoride FCC
Lead FCC
Assay USP
Residu on Ignition USP

Limit of Free Ethylene

USP
Oxide and 1,4-Dioxane

Limit of Ethylene Glycol

and Diethylene Glycol
(for PEG having a USP
nominal molecular
PEG 300
weight less than 450)

Hydroxyl Value EP
DIN 51562,
Viscocity
98.9°C or EP
 EN13267 or
Water Content
EP
Monoethylene glycol +
EP
Diethylene glycol total
Residual Ethylene Oxide EP
Dioxan EP
Formaldehyde EP
 Konfirmasi Lab Eksternal
Spesifikasi Bisa Bisa
Method sesuai Menggunakan
Compendial Method Internal Lab
Max 0.2% calculated as glucose equivalent
Max 09.3% calculated as glucose equivalent
72.0 - 92.0
28.0 - 32.0%
NMT 0.3%
NMT4.0 %
NMT 400 ppm
NMT 25%
94.0 - 100.5 %
60 min at 160oC
(2.9.26. Method 1)
NMT 1.5%
90-105 ml/100 g
> 90%
NMT 5 ppm
NMT 0.3%
NMT 4.0 %
NMT 400 ppm
NMT 25%
94.0 - 100.5 %
60 min at 160oC
(2.9.26. Method 1)

NMT 2%
NMT 1.5%
80-95 ml/100 g
NLT 90 %
NMT 5 ppm

responds to all tests for Potassium Salt and for

Nitrate in the Qualitative Tests.
Colorless and clear
NMT 0.021% as Cl
NMT 2 µg/g as Pb
NMT 3 µg/g as As
NLT 99.0%
37.0 - 49.0 % w/w
5.8 - 9.0 % w/w
≤ 0.5 % w/w
91.0 - 108.1 %
NMT 3ug/g
NMT 5 ug/g
NMT 0.075 %
NLT 1.5%
6.5-16.0 %
NLT 98 % Passes 180 um, 92 % passses75um
o- Toluenesulfonamide: Max 10 ppm
p- Toluenesulfonamide: Max 10 ppm
The sample solution is not more intensely
coloured than a standard solution

Max 15.0%

99.0 - 101.0%
(anhydrous substance)
NLT 5.0% of esters
(Calculated as C12H22O2)
NLT 50.0% of esters
(Calculated as C10H20O, free and as esters)
A white film does not form at the zone of contact
within 1 min
Max. 200 ppm
Max. 200 ppm
Max 2.0%
Max 200 ppm
Max 200 ppm
Max 10 ppm
98.0 - 102.0% (anhydrous basis)
NMT 0.7%
NMT 0.1%

The Rf value of the principal spot of the sample

solution corresponds to that of standard solution
A, and the color of any other single spot from the
sample solution is not more intense than that of
the principal spot from standard solution B (0.5%)

The color of the spot from the sample solution is

not more intense than that from standard
solution B (0.1%)
NMT 2.0%
(Titrimetry Method)
Max 3 ppm
Max 10 ppm
Max 5 ppm
NMT 0.5%
NMT 100 ppm
NMT 5 ppm
Complies
NMT 200 ppm
Complies
98.0 - 102.0%
The retention time of the major peak of the
sample solution corresponds to that of the
menthol peak of the standard solution, as
obtained in the assay.
Individual impurities: NMT 0.5% for
isomenthol and 0.3% for all impurities from
natural and synthetic menthol
Total impurities: NMT 2.0%

Maximum 0.05%

Meets the requirements

Impurity B: Max 50 ppm
Unspecified impurities: for each impurity, max
0.10%
Total: Max 0.5%
Reporting threshold: 0.05%

Conforms to limits
Matches reference GC chromatogram

74.0 to 82.0 %w/w

max. 3 ppm
max. 50 ppm
max. 2 ppm
95.0 - 105.0%
NMT 0.1%
The peak areas for ethylene oxide and 1,4-
dioxane of the sample solution are NMT those
of the corresponding peaks of the standard
solution corresponding to NMT 10 µg/g of
ethylene oxide and NMT 10 µg/g of 1,4-
dioxane

NMT 0.25% of the sum of ethylene glycol and

diethylene glycol

340-394 mg KOH/g or as specified in the

current pharmacopoeia for EP
5.4-6.4 mm2/s or as specified in the current
pharmacopoeia for EP
Max 2.0%

As specified in the current pharmacopoeia

As specified in the current pharmacopoeia
As specified in the current pharmacopoeia
As specified in the current pharmacopoeia
rmasi Lab Eksternal
(Method Internal)
Instrumen yang Tidak bisa
digunakan