1，1-DIMETHYLBIGUANIDE HYDROCHLORIDE NEW

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Shaanxi TNJONE Pharmaceutical Co., Ltd

1YR

China

Chemical Properties

Product Name	1，1-DIMETHYLBIGUANIDE HYDROCHLORIDE
CAS No	15537-72-1
EC-No	605-006-2
Min. Order	1kg
Purity	99%
Supply Ability	20tons
Release date	2024/04/05

Company Profile Introduction

PRODUCT	METFORMIN HYDROCHLORIDE		PHARMACOPOEIA	EP9.0
BATCH NO.	A-81411904109	GROSS WEIGHT	27.5Kg/Drum
BATCH QUANTITY	2000KGS	NET WEIGHT	25Kg/Drum
TEST ITEM	STANDARDS REQUIRED		TEST RESULTS
Characters Appearance Identification B:IR-spectrum E: reaction of chlorides Test Appearance of solution Related substances Cyanogunadine(imp.A) Any other impurity Total impurities Impurity F Heavy metals Loss on drying Sulphated ash Residual solvents Methanol Assay% on dry basis Bulk Density Particle Size	White or almost white crystals		white crystals
	Consistent with the spectrum of metformin-
	hydrochloride CRS. (2.2.24)		Complies
	It gives reaction of chlorides. (2.3.1)		Complies
	Clear(2.2.1) and colorless(2.2.2 Method II)		clear and colorless
	(2.2.29)
	≤0.02%		0.0005%
	≤0.05%		0.004%
	≤0.2%		0.007%
	≤0.05%		<LOQ(LOQ=0.01%)
	≤10ppm (2.4.8)		<10ppm
	≤0.5% (2.2.32)		0.05%
	≤0.1% (2.4.14)		0.04%
	≤3000ppm		731ppm
	98.5-101.0%(2.2.20)		99.8%
	Not less than 0.40g/ml		Comply
	100% pass 40mesh		Comply