Zidovudine, Stavudine, Nevirapine & Lamivudine

• Function: Blood System Agents
• Certification: GMP
• Grade Standard: Medicine Grade
• Type: Chemical Reagent
• State: Solid
• Volatile: Not Volatile
• Model NO.: LMV
• Odor: Odorless
• Form: Powder
• Transport Package: 25kgs/drum
• Specification: USP
• Trademark: Fraken
• Origin: China
• HS Code: 2938901000
• Production Capacity: 100kgs

Product Description

Zidovudine

Tests	Specifications	Results
Characters	White or off white crystalline powder	Complies
Identification	IR:similar to Reference Standard	Complies
Appearance of solution	powder	Complies
Specific Rotation	-127°to -132°	-131°
Loss on Drying	≤0.5%	0.06%
Sulphated Ash	≤0.2%	0.03%
Heavy metals	≤0.002%	Complies
PH	2.0 - 2.6	2.3
Related Compouds	1.    Single Impurity ≤1.0% 2.    Sum of Impurity≤2.0%	Undetected Undetected
Assay(Anhydrous)	98.0% -101.5%	100.2%

Stavudine

Item	Requirements	Test Results
Description	White to off- white crystalline powder	Complies
Water	≤0.20%	0.06%
Light absorption(50mg/ml,440nm,4cm)	≤0.0015	Complies
Total impurities	≤0.60%	0.14%
Other individual impurity	≤0.10%	0.01%
Relative retention time at about 0.4 impurity	≤0.30%	0.01%
Relative retention time at about 0.90 impurity	≤0.20%	0.11%
Total residual solvents	≤0.3%	0.14%
Assay(On the anhydrous basis)	98.0%~102.0%	99.6%

Nevirapine

TESTS	Specification	RESULTS
Appearance	White or off-white crystalline powder	White crystalline powder
Identification	IR absorption spectrum of a potassium bromide dispersion of the sample is concordant with that of a similar preparation of Nevirapine USP RS/working hard	conforms
	HPLC the retention time of the majir peak of the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard prepartion,as obtained in the assay	conforms
Solubility	Practically insoluble in water,slightly insoluble in ethanol and methanol	conforms
water	≤0.2% w/w	0.11%
Residue on ignition	≤0.1%	0.03%
Heavy metals	≤0.001%	<0.001%
Nevirapine related compound A	≤0.2%	0.01%
Nevirapine related compound B	≤0.2%	0.01%
Nevirapine related compound C	≤0.2%	0.004%
Another individual unspecified impurity	≤0.1%	0.01%
Total impurities	≤0.6%	0.03%
Organic volatile impurities	O-Xylene   ≤2170ppm	ND
	Dimethylformamide≤880ppm	ND
	Methanol ≤3000ppm	9ppm
	ethylacetate≤5000ppm	195ppm
Assay (HPLC)	C15H14N4O   98.0% ~102.0%	100.3%
Conclusion	Comply with the USP31 standard

Lamivudine

Item	Requirements	Test Results
Description	White to off- white crystalline powder	Complies
Light Absorption	Not more than 0.015(440nm,4cm cell, 50mg/ml)	Complies
Water	≤0.20%	0.06%
Light absorption(50mg/ml,440nm,4cm)	≤0.0015	Complies
Total impurities	≤0.60%	0.14%
Other individual impurity	≤0.10%	0.01%
Relative retention time at about 0.4 impurity	≤0.30%	0.01%
Relative retention time at about 0.90 impurity	≤0.20%	0.11%
Total residual solvents	≤0.3%	0.14%
Ethanol	≤0.20%	0.14%
Assay(On the anhydrous and solvent-free basis)	98.0%~102.0%	99.6%

Cisplatin

ITEMS	SPECIFICATIONS	RESULTS
Appearance	White crystalline powder, soluble in water, very slightly soluble in acetone and in alcohol	Conforms
Identification	IR	Conforms
Appearance of solution	Solution is clear and colorless	Conforms
Acidity	To 10ml of solution S1 add 0.1ml of phenolphthalein solution R1,the solution is colourless,not more than 0.7 ml of 0.01M sodium hydroxide is required to change the colour of the indicator to pink	Conforms
PH	5.0~7.0	6.3
Loss on drying	≤05%	0.08%
Residue on Ignition	≤0.3%	0.3%
Transmittance	≥97%	97.2%
Water-insoluble matter	≤0.5%	0.21%
Limit of 1,1-cyclobutane- dicarboxylic acid	≤0.5%	N.D
Chromatographic purity:    Individual impurity:     All impurities:	≤0.25%  ≤0.5%	0.077% 0.19%
Platinum content	52.0% - 53.0%	52.33%
Chlorides	≤100ppm	Conforms
Ammonium	≤100ppm	Conforms
Silver	≤10ppm	Conforms
Soluble barium	≤10ppm	Conforms
Assay	98.0%-102.0%	99.2%
Conclusiion	This product complied with the standard of USP 32 & EP5

Mycoplasma Storage: Store below 30º C, away from direct sunlight, keep out of the reach of children.
Package: As your request.
Shelf Life: Two years when properly stored.
Delivery: Within two weeks after receiving your prepayment.

Service we can provide:
1. Mixed container, we can mix different items in one container.
2. Quality control, before shipment, free sample for test. After shipment, keep sample for 3 years
3. Prompt shipment with professional documents
4. Packing as your request, with photo before shipment.

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To get more information, just feel free to contact with us. Thanks.
Mr. Liu
Qingdaofraken international trading Co., Ltd
Address: RM1005 post mansion yan'an three road, qingdao, China
Tel: [phone]
Fax: [phone]
Web: http://fraken.en.made-in-china.com