（NS/R-22-07） № 1811073

Product

Propylene glycol

Grade

Pharmaceutical Excipients

Quantity

25kg x 12drums

Shelf life

12months

Batch NO.

181024251B

Basis

CP2015,4th Edition

Content

Specification

Test Result

【Appearance】

It should be colorless and sticky liquid; odorless, easy to be wet.

Colorless and sticky liquid; odorless, easy to be wet.

【Solubility】

It should be miscible with water, ethanol or trichoromethane.

Miscible with water, ethanol or trichoromethane.

Density（25℃）

It should be 1.035～1.037

1.035

Refractive index

It should be 1.431～1.433

1.431

【Identification】

（1）The main peak of solution keeping time

It should be similar to the main peak of the reference.

Complies

（2）IR

The IR spectrum should be similar to the Reference Spectrum（Picture.706）

Complies

【Test】

Acidity

It should comply with the specification in reference

Complies

Chlorides

NMT 0.007%

Complies

Sulfates

NMT 0.006%

Complies

Oxidized substances

It should comply with the specification in Reference.

Complies

Reductions

It should comply with the specification in Reference.

Complies

Related substances

Diethylene Glycol

NMT 0.001%

Complies

Dipropylene glycol

NMT 0.1%

Complies

tripropylene glycol

NMT 0.03%

Complies

Epoxy propane

NMT 0.001%

Complies

Water

NMT 0.2%

0.06%

Residues on burning

NMT 2.5mg

2.2mg

Heavy metals

NMT 5ppm

Complies

Arsenic salt

NMT 0.0002%

Complies

【Assay】

NLT 99.5%

99.7%

Conclusion：Comply with the CP2015, 4th Edition.

Date：2018-10-26

Tester: Chengsheng Lin

Reviewer: Shasha Song