انالیز پودر تالک داروییReviewed by Roka on Oct 2Rating:

مشخصات فنی پودر تالک بهداشتی/ داروی 

(Certification of Analysis (COA

TALC POWDER

NAME OF MATERIAL: TALC POWDER

:QUNTITY 

BATCH NO: T-0275

GRADE :USP

 

EXP DATE :NOV 2021

MFG DATE: DEC 16

ANALYSIS AS PER :USP-32

 

 

RESULT

LIMIT

TESTS

NO

Complies

Very fine whiter of grayish white crystalline powder is unctuous adheres readily to the skin and is free from grittiness

CHARACTERS

1

Passes

Practically insoluble in water and in dilute solutions of acids or alkali hydroxides

Solubility

2

Complies

 

 

Passes

 

 

Passes

The Particle are Notably Stained By a Solution of Methylene Blue

 

A white crystalline precipitate should Be produced.

 

A white Ring should Be Formed Around the drop water

Identification  A

 

 

Identification B

 

 

Identification C

 

3

Complies

Not  more than 0.4 ml of 0.01 N Hcl

Acidity or Alkalinity

4

Less than 10 ppm

Should be required

IRON

5

Less than 2.0% 

Not more than 10 ppm

Acid soluble substances

6

Less than 10 mg

Not more than 10 mg

Water solublesubstances

7

0.50%

Not more than 1.0%

Loss on drying

8

Complies

Total bacteria count should not be more than 1000 CFU/ GM &total molds &yeasts should not be more than 100 CFU/ GM

Microbial limit

9

Less than 7.0%

Not more than 7.0%

Loss on ignition

10

Less than 0.001%

 

Not more than 0.001%

Lead

11

Less than 0.9%

Not more than 0.9%

Calcium

12

Less than 2.0%

Not more than 2.0%

Aluminum

13

 

IR absorption spectrum should not give absorption band at 758±1 cm -1or give IR spectrum after ignition should not give absorption band at 758±1 cm -1

Absence of asbestos

14

 

%Between 17.0% to 19.5 

Content of magnesium

15

                 Conclusion: material meet the requirement of USP 32 specification.

 

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