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Raw Materials

Product Names:

Controlled materials after getting import license such as:

 
 
 
 
 
  Paracetamol DC90 BP98/USP24
  Dexamethasone base BP98
  Ketotifen
  Dexamethasone base BP98 (Micro Powder)
  Mefenamic Acid BP2000
  List Of products
   

 

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

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