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Uniformity of Fill Weight IP 2014,vol.I, page 256, 2.5.3 Average Fill Weight
80 mg to 300 mg 10 %
Average Fill Weight
More than 250 mg 7.5 %
Disintegration IP 2014, Vol. I, page 251, 2.5.1 1 Minute to 60 Minutes
Uniformity of Fill Volume IP 2014, Vol. I, page 256, 2.5.6 Average Fill Volume
40 mL to 50 mL 9 %
Average Fill Volume
50 mL to 200 mL 4.5 %
Average Fill Volume
200 mL to 300 mL 3 %
Syrup pH IP 2014, vol. I, page 169, 2.4.24 1 to 12
Weight per mL IP 2014, Vol. I, page 208, 2.4.29 0.7 g/mL to 1.5 g/mL
Uniformity of Fill Weight IP 2014, Vol. I, page 256, 2.5.6 Average Fill Weight
1 g to 15 g 9 %
B. Finished Products
Multimineral
Tablets
(Winosule Forte
Tablet)
eq. to elemental Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 110 % w/w
Zinc 7.5 mg
Essential Micro-
Nutrients
and Anti-Oxidants
Tablets
(Regold Tablet)
Vitamin E acetate Identification GTP No. QC-095 Qualitative
10 IU Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 160 % w/w
Vitamin B1 1 mg Identification GTP No. QC-097 Qualitative
Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 140 % w/w
Vitamin B2 1.1 mg Identification GTP No. QC-099 Qualitative
Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 130 % w/w
Vitamin B6 1.5 mg Identification GTP No. QC-098 Qualitative
Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 130 % w/w
Dibasic Calcium Identification GTP No. QC-112 Qualitative
Phosphate Issue No.:01 Eff. Date: 22/01/14
eq. to elemental Assay 80 % w/w to 110 % w/w
Calcium 162 mg
Alphalipoic Acid Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to115 % w/w
100 mg
Zinc Sulphate Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to110 % w/w
61 mg
Vitamin E Acetate Identification GTP No. QC-095 Qualitative
10 mg Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to115 % w/w
Zinc Oxide eq. to Identification GTP No. QC-107 Issue No.:01 Qualitative
Elemental Zinc 40 Eff. Date: 22/01/14
mg Assay 80 % w/w to110 % w/w
Capsules
(All-9 S.G Capsule)
28. Multivitamin and Description STP No.: FP/STP/026-01 As general test S.No. 5,6,7,8
Minerals Softgel Issue No.:02 Eff. Date:19/06/13
Capsule
(Ostogem S.G
Capsule)
Alpha Tocopherol Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to125 % w/w
10 IU Acetate
Lycopene Identification GTP No. QC-117 Qualitative
Preparation 10 % Assay Issue No.:01 Eff. Date:22/01/14 80 % w/w to 130 % w/w
2000 mcg
Identification Qualitative
Vitamin E Acetate Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to130 % w/w
5 mg
36. L-Arginine, Description STP No.: FP/STP/054-02 Qualitative
Glutamine, Issue No.:03 Eff. Date:09/03/14
Vitamins &
Minerals Softgel
Capsules
(Recoverin S.G
Capsule)
Extract, Lycopene,
Grapefruit Seed
Extract,
Reserveratroal &
Astaxanthin
(Starmune-OS S.G
Capsule)
Dibasic Calcium Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 130 % w/w
Phosphate eq. to
elemental Calcium,
100 mg
(as Palmitate) Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to160 % w/w
2000 IU
Vitamin E Acetate Assay Issue No.:01 Eff. Date:22/01/14 80 % w/w to120 % w/w
5 mg
Vitamin E Acetate Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 125 % w/w
5 mg
Vitamin B1 1 mg Identification GTP No. QC-097 Qualitative
Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 150 % w/w
(Eyetamin
S.G Capsule)
Riboflavine Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 150 % w/w
(Vitamin B2)
600 mcg
Vitamin B6 1 mg Identification GTP No.QC-098 Qualitative
Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to150 % w/w
Ferrous Fumarate Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 120 % w/w
76 mg eq. to
elemental Iron
25 mg
Vitamin A Assay Issue No.:01 Eff. Date: 22/01/14 80 % w/w to 160 % w/w
Concentrate
(Oily form as
Palmitate)
2000 IU
(Bestage S.G
Capsule)
C. Raw Materials
1. General Tests Acid Value IP 2014, vol. I, page 100,2.3.23 0.1 to 4.0
Clarity And Color of Solution/ IP 2014, vol. I, page 129, 2.4.1 Qualitative (Comparative)
Appearance of solution
Identification
By Chemical IP 2014 Qualitative (Comparative)
BP 2013
USP35 NF30
Loss On Drying IP 2014, vol. I, page 162, 2.4.19 More than 0.05 % w/w
Loss On Ignition IP 2014, vol. I, page 163, 2.4.20 More than 0.05 % w/w
Melting Range/ Melting Point IP 2014, vol. I, page 164, 2.4.21 30 C to 300 C
Nitrogen Content IP 2014, vol. I, page 103, 2.3.30 2.0 % w/w to 15 % w/w
Optical Rotation and Specific IP 2014, vol. I, page 167, 2.4.22 -180 to +180
Rotation
Residue on Ignition/Total Ash IP 2014,vol.I,page 98, 2.3.19 More than 0.05 %w/w
Sulphated Ash IP 2014, vol. I, page 98, 2.3.18 More than 0.05 %w/w
Water by KF IP 2014, vol. I, page 113, 2.3.43 0.05 % w/w to17 % w/w
Bulk Density IP 2014, vol. I, page 224, 2.4.35 0.1 g/mL to 3 g/mL
Particle Size IP 2014, vol. I, page 259, 2.5.7 2 % w/w to 100 % w/w
2. Alpha Lipoic Acid Assay USP34 NF29, page 1186 99 % w/w to 101 % w/w
3. Ferrous Gloconate Assay IP 2014,vol. II, page 1752 95 % w/w to 102 % w/w
Ferric iron IP 2014,vol. II, page 1752 0.1 % w/w to 3.0 % w/w
4. Biotin Assay USP34 NF29, page 2046 97.5 % w/w to 100.5 % w/w
6. Dibasic Calcium Assay IP 2014,vol. II, page 1258 98 % w/w to 105 % w/w
Phosphate
Acid insoluble substance 0.01 % w/w
7. Ferrous Fumarate Assay IP 2014,vol. II, page 1750 93 % w/w to 101 % w/w
IP
9. Lysine Assay USP34 NF29, page 3352 98.5 % w/w to 101.5 % w/w
Hydrochloride
USP
13. Calcium D Assay IP 2014,vol. II, page 1257 98 % w/w to 101 % w/w
Pantothenate
15. Cyanocobalamin Assay IP 2014,vol. II, page 1474 96 % w/w to 102 % w/w
16. Green Tea Extract Assay STP No. RM/STP/078-01 NLT 50 % w/w of labeled
Issue No.:02 Eff. Date:15/02/13 claim
17. Nicotinamide Assay IP 2014,vol. III, page 2332 99 % w/w to 101 % w/w
18. N-Acetylcystein Assay USP34 NF29, page 1759 98 % w/w to 102 % w/w
19. Potassium Iodide Assay IP 2014,vol. III, page 2526 99 % w/w to 100.5 % w/w
21. Thiamine Assay IP 2014,vol. III, page 2859, 98 % w/w to 102 % w/w
Mononitrate IP STP No. RM/STP/313-02
Issue No.:03 Eff. Date:04/03/14
22. Vitamin A Assay IP 2014,vol. III, page 2975 95 % w/w to 110 % w/w of
Concentrate Oil stated no. of units of vitamin
(Palmitate) A per g
23. Vitamin A Assay IP 2014,vol. III, page 2975 95 % to 115 % w/w of stated
Concentrate no. of units of vitamin A per
Powder (Acetate) g
27. Vitamin B2 Assay IP 2014,vol. III, page 2657 98 % w/w to 101 % w/w
(Riboflavin)
Light Absorption Qualitative (Comparative)
28. Vitamin B6 Assay IP 2014, Vol. III, page 2600 99 % w/w to 101 % w/w
(Pyridoxine
Hydrochloride)
29. Cholecalciferol Assay IP 2014,vol. II, page 1382 97 % w/w to 103 % w/w
(Vitamin D3 )
Light Absorption Qualitative (Comparative)
30. Tocopheryl Acetate Assay STP No. RM/STP/021-03 46 % w/w to 102 % w/w
50% Powder Form Issue No.: 03 Eff. Date:27/06/14
(Vitamin E
Acetate)
31. Ascorbic Acid Assay IP 2014,vol. II, page 1086 99 % w/w to 100.5 % w/w
(Vitamin C)
Light absorption Qualitative (Comparative)
32. Calcium Assay IP 2014,vol. II, page 1248 98 % w/w to 100.5 % w/w
Carbonate
33. Zinc Sulphate Assay IP 2014,vol. III, page 3012 99 % w/w to104 % w/w
34. Zinc Oxide Assay IP 2014,vol. III, page 3010 98 % w/w to 100.5 % w/w
35. Magnesium Assay IP 2014,vol. II, page 2144 99 % w/w to 101.5 % w/w
Sulphate
36. L-Isoleucine Assay USP34 NF29, page 3201 98.5 % w/w to 101.5 % w/w
37. L-Glutamic Acid Assay USP34 NF29, page 1169 98.5 % w/w to 100.5 % w/w
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