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Products

Prophylactic Biological Products

98% up by HPLC, EP/USP Irbesartan 138402-11-6

Category:

Prophylactic Biological Products

CAS NO:

138402-11-6

Standard:

USP,BP,EP,JP,In-house Standards,

Price Range:

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Main Sales Markets:

North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

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Sinoway Industrial Co. Ltd

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Basic Info

CAS Number

138402-11-6

Pharmacopoeia

USP,BP,EP,JP,In-house Standards

Grade

Pharmaceutical Grade

Is Manufacturer

YES

Packaging & Delivery

Packaging Specification

25kg/drum 1kg/bottle

Delivery Cycle

7 days after payment

Product Description

Product Information

Product name	Irbesartan
CAS No.	138402-11-6
Molecular Formula	C25H28N6O
Molecular Weight	428.53
Quality Standard	98% up, USP/ EP
Appearance	White to almost white powder

COA of Irbesartan

ITEMS	STANDARDS	RESULTS
Appearance	White to off-white powder	White powder
Identification	Infrared absorption: The IR spectrum is consistent with that obtained with the reference	Conforms
Identification	The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay	Conforms
Water	NMT 0.5%	0.24%
Limit or Azide	NMT10ppm	Not detected
Heavy metals	NMT0.002%	Conforms
Related compounds (HPLC)	Compound A NMT0.2%	0.01%
	Any other impurity NMT0.1%	0.04%
	Total impurity NMT0.5%	0.09
Residual solvents(GC)	Ethanol NMT 5000ppm	2307 ppm
	Toluene NMT 890ppm	238 ppm
	Dichloromethane NMT3000 ppm	Not detected
	N,N-Dimethylformamide NMT880 ppm	Not detected
	T-butyl Methyl Ether NMT 5000 ppm	Not detected
Assay	98.0—102.0%	99.2%
Conclusion	The analysis results show that this batch of irbesartan conforms to USP