Paliperidone CAS NO.144598-75-4

Prodcut name

Paliperidone

Synonyms

9-Hydroxyrisperidone; 6,7,8,9-Tetrahydro-3-(2-(4-(6-fluro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-9-hydroxy-2-methyl-4H-pyrido[2,1-a]pyrimidin-4-one

MOQ

1G

CAS No.

144598-75-4

Appearance

white to off white crystalline powder

Molecular Formula

C23H27FN4O3

Molecular Weight

426.48

Assay

98.0~102.0%

Application

Pharma grade or research purpose

Identification

A.H-NMR:Comply with the structure

Complies

B.LC-MS:Comply with the structure

Complies

C.The IR spectrum of sample should be identical with that of reference standard;

Complies

D.HPLC-ESI-MS

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.

Complies

Crystallinity

meets the requirements.

Complies

Loss on drying

≤2.0%

0.19%

Heavy metals

≤10 ppm

<10ppm

Water

≤1.0%

0.1%

Sulphated ash

≤0.5%, determined on 1.0 g.

0.009%

Related substances

Unspecified impurities: for each impurity

≤0.10%

<0.10%

Total Impurity

≤0.5%

0.18%

Purity

≥99.0%

99.7%

Assay

99.0%~101.0% (anhydrous substance).

99.8%

Microbiological Analysis

Total plate count

≤1000cfu/g

Complies

Yeast and Moulds

≤100cfu/g

Complies

E. Coli.

Absent

Negative

Salmonella

Absent

Negative

S.aureus

Absent

Negative

Storage

Preserve in well-closed, light-resistant and airtight containers.

Complies