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Authoritative certification TNN Bimatoprost

Bimatoprost is currently considered the most powerful topical antiglaucoma drug for lowering IOP. It is effective for normal people, patients with POAG and OHT. It is primarily used for patients with POAG or OHT who are intolerant of or ineffective with other IOP-lowering medications.

Description

Bimatoprost

Analysis

 

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Standard

Result

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White to almost white powder

White powder

Identification (IR KBr)

The absorption intensity in the chromatogram of the test sample is the same as that of the standard.

Compliant

Solubility test

Testing a sample in ethanol solution for solubility

Compliant

TLC

One main place

Correspond

Purity (HPLC)

97.0 percent Min.

99.95 percent

5-Trans isomer

Less than or equal to 3.0 percent

0.04 percent

15(S)-isomer

Less than or equal to 1.5 percent

0.03 percent

Bima acid

Less than or equal to 1.5 percent

no data

Total related impurities

Less than or equal to 3.0 percent

0.05 percent

Optical rotation

plus 33.0 degrees -- plus 37.0 degrees (20 degrees CH3CN)

plus 35.5 degrees

Remaining solvent

Ethanol Less than or equal to 5000 ppm

no data

 

Acetonitrile Less than or equal to 400 ppm

no data

 

Ethyl acetate Less than or equal to 5000 ppm

no data

 

Heptane Less than or equal to 5000 ppm

no data

Ignition residue

Less than or equal to 0.5 percent

Correspond

Heavy metals

Less than or equal to 10 ppm

Correspond

Damage due to drying out

Less than or equal to 1.0 percent

0.4 percent

analysis

97.0-102.0 percent (anhydrous base)

100.50 percent

Storage

Store in an airtight container, protected from light, at +2--8DC. current for 3 years.

Conclusion

Performed in accordance with Internal Standard version 20080401

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Statement

It can be used for eye care/glaucoma treatment and eyelash/hair growth liquid.

Peculiarity

High purity

High activity

Package

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Package:

10 g/bottle, 50 g/bottle

Details

CAS number: 155206-00-1

MF: C25H37NO4

Purity: 97 percent min.

Place of Origin: China (Mainland)

Brand name: TNN

Appearance: White to off-white powder

 

product-1-1

Please contact bimatoprost, our current ISO 9001/14001/18001 quality management system has been completed, and we have accepted nearly 60 audits from domestic and foreign pharmaceutical factories, institutions and drug regulatory authorities. Therefore, the quality system hidden under quality scores has a deep foundation.

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