controlled materials after getting importe licen's such as:
codeine phosphate,ephedrin Hcl,Pseudo ephedrin Hcl,chlordiazepoxide
Xian medicines and health products
import and export Co.
Certificate of
analysis
|
Batch No: 0204138 |
Date of Anal: 2002-04-17 |
| Product Name: PARACETAMOL
DC90 BP98/USP24 |
Exp Date: 2005-04
|
| Quantity: 1000KGS |
Packing: 2KG/Drum |
| Test Item |
Specification |
Test Result |
| Appearance |
White, free-flowing granules |
Complies |
| Identification |
Complies |
Complies |
| Assay |
87.5% - 92.5% (On dry substance) |
88.64% |
| Loss on drying |
0.5% - 2.5% |
1.82% |
| Bulk Density |
0.50 - 0.80g / CM3 |
0.64g / CM3 |
| Disintegration |
<5 min |
2" 42" |
| Dissolution |
>80% |
86.94% |
| Heavy Metals |
<0.0010% |
<0.0010% |
| Hardness |
>7Kgf |
10.5kgf |
| Retained on USS20 |
Report |
9.29% |
| Retained on USS40 |
Report |
52.41% |
| Retained on USS60 |
Report |
76.95% |
| Accumulated on USS80 |
>75% |
85.13% |
| Pan |
<25% |
14.87% |
|
Microbiological Test
|
| Germs |
<500/g |
<10/g |
| Mold |
<50/g |
<10/g |
| Colon Bacillus |
None |
None |
Determination
The Product Complies with
BP98/USP24
Manufacture
HUAHOU
SYNTHETIC PHARMACEUTICAL FACTORY
Xian medicines and health products
import and export Co.
Certificate of
analysis
|
Batch No: M-040306 |
Date of Anal: 2004-03-18 |
| Product Name: Dexamethasone base BP98
(Micro Powder) |
Exp Date: 2007-03-18
|
| Quantity: 4KGS |
Packing: 1KG /Tin;4Tin/Carton
|
| Test Item |
Specification |
Results |
| Characteristics |
White or Almost White Crystalline
Powder |
Complies |
| Identification |
Complies |
Complies |
| Melting Point |
About 255C° |
257C° |
| Special Optical Rotation |
+75 o - +80 o |
+77.3 o |
| Light Absorption |
380-410 o |
397.4 o |
| Related Substance |
Complies |
Complies |
| Loss on Drying |
<0.5% |
0.2% |
| Microne (Microscope) |
It contains 80% below 5UM It contains 98% below
30UM |
Complies Complies |
| Assay |
96.0 - 104.0% (Calculate on C 22H 29FO 5) |
99.1% |
Determination
The Product Complies With
BP98
Manufacture
Zhejiang
medicine Co. LTD Xianju pharmaceutical factory
Xian
medicines and health products import and export Co.
Certificate of
analysis
| Batch No: S340201 |
Date of Anal: 2004-03-18 |
| Product Name: Ketotifen furmarate
CP2000/JPC1998 C 23H 33NO 5S 425.5 |
Exp Date: 2007-2-5
|
| Quantity: 5KGS |
|
| Test Item |
Specification |
Results |
| Description |
White to off-white crystalline
powder, Odourless, Bitter taste |
Complies |
| Solubility |
Sparingly soluble in methanol, In
ethanol, Slightly soluble in water, Insoluble in
chloroform |
Complies |
| Identification |
UV and IR spectrum |
Positive |
| Melting Point |
190 -195C with decomposition |
194.5 –195C |
| Clarity and Colour of
Solution |
Clear and no more colour than
matching E |
Complies |
| Heavy Metals |
<20PPm |
<20PPm |
| Chloride |
<0.015% |
<0.015% |
| Related Substance (T.L.C)
|
Individual impurity<0.2% |
<0.2% |
| Loss on Drying |
<0.5% |
0.24% |
| Residue on Ignition |
<0.2% |
0.02% |
| Assay(Potentiometric
Titration) on the dried basis |
>99% |
99.34% |
Determination
The
Product Complies With CP2000/JPC1998
Manufacturer
SHANGHAI
SHENXING PHARMA FACTORY
Xian medicines and health
products import and export Co.
Certificate of
analysis
|
Batch No: M-040307 |
Date of Anal: 2004-03-20 |
| Product Name: Dexamethasone base BP98
(Micro Powder) |
Exp Date: 2007-03-20 |
| Quantity: 2KGS |
Packing: 2KG /Tin |
| Test Item |
Specification |
Results |
| Characteristics |
White Powder or Crystalline |
Complies |
| Identification |
Complies |
Complies |
| Melting Point |
About 230C |
230 C |
| Special Optical Rotation
|
+98 o - +102 o |
+99.7 o |
| Light Absorption |
400-430 |
410 |
| Related Substance |
Complies |
Complies |
| Loss on Drying |
<1.0% |
0.3% |
| Microne (Microscope) |
90% < 5um |
Complies |
| Assay |
96.0 - 104.0% (Calculate on C 21H 28FO 5) |
99.1% |
Determination:
The
Product Complies With BP98
Manufacture:
Zhejiang
medicine Co. LTD Xianju pharmaceutical factory
Xian medicines and health
products import and export Co.
Certificate of
analysis
| Batch No:
MA-031219-1 |
Date of Anal: 2003-12-20 |
|
Product Name: Mefenamic Acid BP2000 (Granulator;
Bulk Density: 0.7g/ml) |
Exp Date:
2007-12-20 |
| Quantity: 500KGS |
Packing: 25KG/Drum
|
| Test Item |
Specification |
Results |
| Description |
A white microcrystalline powder |
Complies |
| Identification |
A IR test
B UV test
C Colour
test
D Fluorescence Test |
Complies
Complies
Complies
Complies
|
| Related Substance |
<0.2% |
0.03% |
| Loss on drying |
<0.5% |
0.25% |
| Sulphated Ash |
<0.1% |
0.03% |
| Absorption Spectrum |
A 279nm = 0.69-0.74 A 350nm = 0.56-0.60 |
0.72 0.58 |
| Copper Saly |
<10PPm |
Complies |
| Bulk Density |
0.6-0.75G/ML |
0.72G/ML |
| 2,3-Dimethyl Aniline |
<100PPm |
Complies |
|
Content (Base on dry sample) |
99.0%-100.5% |
99.78% |
Determination:
The Product Complies With BP2000
List of Products
| Albendazole |
Furaltidon base |
Probyl paraben |
| Ammon .chloride |
Gentamycin sulphate |
Probylen glycol |
| Acacia gum |
Gelatin |
Poly ethylen glycol 4000 |
| Aerosil |
Glucose anhydrus |
Poly ethylen glycol 400 |
| Ascorbic acid |
Glycerol guaicolate |
Poly ethylene glycol 1500 |
| Ascorbic acid (vit.C) |
Guaifenesin |
Poly ethylene glycol 6000 |
| Aspartame |
Glimepride 98% |
Ranitidine Hcl |
| Atenolol |
Hydrocortison. acetate |
Riboflavine Hcl |
| Avecil 101 |
H.P.M.C |
Resorcinol |
| Aluminum foil |
Hydroxycobalamine Hcl |
Retinoic acid |
| Aminophyllin |
Lactose monohydrate |
Simithecon |
| Benzalkonium chloride |
Lactose anhydrus |
Sulphacetamide sod |
| Betamethasone |
Levamesol Hcl |
Salbutamol sulphate |
| Betamethason17-valerate |
Lactic acid |
Starch corn |
| Bee wax |
Lanoline wool fat |
Sod.cromoglycate |
| Betamethason.dipropionate |
Lignocaine Hcl |
Sod.saccharin |
| Benzoic acid |
Mag.stearate |
Sod.benzoeate. |
| Bismuth subgallate |
Mannitol 2.35 $ |
Sod.citrate |
| Clobetasol propionate |
Methylparaben |
Sod.algenate |
| Chlordiazepoxide |
Mefenamic acid |
Sod. algenate |
| Chlorpheneramine maleate |
Meloxicam |
Salicylic acid |
| Chloramphenicol base1 |
Metaclopromide |
Silver Sulphadiazine |
| Chloramphenicol palmitate |
L-Methyl dopa |
Sulphadiazine base |
| Cyanocobalamine |
DL-Methyl dopa |
Sulphamethoxazole |
| Chlorhexidine gluconate 20% |
Methyl salcylate |
Sulphamethoxazol |
| Camphor powder |
Metronidazol |
Sorbitol |
| Cetomacrogyl 1000 |
Metronidazol benzoate |
Sorbitol 70 % pharma grade |
| C.M.C |
Menthol |
Tartaric acid (L+) |
| Ciprofloxacine Hcl |
Miconazole nitrate |
Tartaric acid (DL) |
| Colistin sulphate |
Miconazol |
Tartaric acid (D-) |
| Captopril |
Mebendazole |
Tart. acid (DL )anhydrous |
| Carbamazepin |
Metformine Hcl |
Tararic acid (DL) mono. |
| Chlorpromazin Hcl |
Minoxidil |
Theophyllin Anhydrous |
| Clotrimazol |
Nystatin |
Trimethoprim |
| Cyproheptadine Hcl |
Nifedipine |
Talc powder |
| Dexamethasone |
Naproxen |
Titanium dioxide |
| Dextrometherphan. Hbr. |
Niclosemide |
Tylosin Tartaric |
| Diphenhydramine Hcl |
Noemycin sulph |
Tween 20 |
| Diaveridine |
Norfloxacin |
Tri-ethanolamine |
| Disod.Editate |
Nalidixic acid |
Tetramisole |
| Dicalcium phos. dihy. |
Nicotinamide |
Vit D2 |
| Dipyrone powder |
Nicotinamide |
Vit. B12 |
| Doxycyline Hcl |
Oleic acid |
Vit. B6 |
| Dextrose anhydrous |
Ornidazole |
Vit.B1 mono. |
| Aluminium.cap28m |
Oxytetracyclin base |
Vit.B1 (thiamine Hcl ) |
| Empty.botteles.120cc |
Oxytetracyclin Hcl |
Vit.B2 (Riboflavin Hcl) |
| Embrolium |
Paraffin |
Vit.D3 |
| Enrofloxacin base 99% |
Pot. phosphate monobasic |
Vit.A |
| Enrofloxacin Hcl 99% |
Pseudoephedrin Hcl |
Vit.E (oil) |
| Folic acid |
Paracetamol |
Vaselin (white) |
| Flucinolon acetonide |
Paracetamol DC90 |
Vee gum |
| Fenbendazole |
Potassium citrate |
Witepsol H37 |
| Ferrous fumarate |
Phenylepherin Hcl |
Witepsol H35 |
| Ferrous gluconate |
Peppermint oil |
Witepsol H37 |
| Flumequine |
Propranolol |
Witepsol H35 3 |
| Fluconazol |
Piroxicam |
Xanthan gum |
| Felodipine 98.5%-101% |
Prednisolone base |
|
| Furaltidone Hcl |
P . V . P – K30 |
| |
