Amoxicillin com/micro

Name of Product

Amoxicillin Trihydrate Micronized

Batch No.

XQ2104054

Net Weight

100.00kg

Packing

25.00kg/drum

Mfg .Date

2021-04-21

Expiry Date

2025-03

Date of Report

2021-04-27

Specifications

BP + In-house standard

TESTS

SPECIFICATIONS

RESULTS

1.Description

White or almost white crystalline

White crystalline powder

2.Solubility

powder

Slightly soluble in water, very slightly

 soluble in ethanol (96 per cent),

practically insoluble in fatty oils. It

3.Identification

dissolves in dilute acids and dilute

 solutions of alkali hydroxides.

IR:The  spectrum  of  the  sample 

corresponds to that of CRS.

TLC: The principal spot in the

chromatogram obtained with the test

solution is similar in position, colour 

and size to the principal spot in the

chromatogram  obtained  with  reference

solution  (a).

Chemical test: A dark yellow colour 

develops.

Conforms

4.Appearance of

solution(in HCI/NH₄OH)

Not more opalescent than reference 

suspension   Ⅱ

Conforms

5.pH

3.5-5.5

5.0

6.Specific optical rotation

+290°~+315°

+306°

7.Water

11.5%-14.5%

13.0%

8.Assay(anhydrous)

95.0%-102.0%

99.4%

9.Related   substances

Any   impurity:≤1.0%

0.07%

10.Residual  solvents

N,N-Dimethylaniline:≤20ppm

Acetone:≤0.5%

(Not used in process)

11.Sulfated  ash

Methanol:≤0.3%

≤1.0%

0.008%

0.040%

12.Particle size

d(90)

15.9μm

CONCLUSION:The results conform with BP + In-house standard.