Pharmaceutical Tenofovir Alafenamide Fumarate 1392275-56-7

Batch No.

HF170808

Quantity

23.8kgs

Mfg. Date

Aug. 08, 2017

Package

As required

Rep. Date

Aug. 11, 2017

Exp. Date

Aug. 07, 2019

Items

Standards

Results

Appearance

White to off-white or tan, slightly hygroscopic crystalline powder

Complies

Identification

By IR

Complies

By HPLC

Complies

Solubility

In aqueous media,soluble at low pH(pH=2.0), sparingly soluble at pH 3.8, and slightly soluble at pH up to 8.0, freely soluble in methanol, soluble in ethanol, sparingly soluble in isopropanol and slightly soluble in acetone

Complies

Water Content(KF)

≤0.50%

0.42%

Heavy Metals

≤20ppm

Complies

Residue on Ignition

≤ 0.10%

0.08%

Related Substances

Any individual unknown impurity: ≤0.20%

0.08%

Total impurities: ≤0.50%

0.37%

Fumaric Acid Content

10.0%~12.0%(w/w)

11.0%

Assay

98.0%~102.0% on anhydrous basis

99.66%

Reference Standard

In-house Standard

Conclusion

The product complied to In-house standard.

Storage

Preserve in tight,light-resistant containers in a cool place