AEROSIL-200 (Colloidal Anhydrous Silica) Raw Material, in Pharma is a high purity amorphous anhydrous colloidal silicon dioxide for use in pharmaceutical products which fulfils the analytical requirements of the currently valid versions of the British Pharmacopeia. It is complete testing according to pharmacopoeia methods.

 

TABLE OF CONTENTS

1. Purpose
2. Scope
3. Responsibilities
4. Abbreviations
5. Procedure
6. Quality Records
7. Reference
8. List of recipients

AMENDMENT STATUS
Sr.#	Date of Amendment	Issue Status	Page No	Page Status	Details of change / review
1
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Written by	Checked by	Approved by	Authorized by
Analyst	Quality Control Manager	Quality Assurance Manager	General Manager Plant
Date:	Date:	Date:	Date:

Instruction: Coping of this document in part or whole is strictly prohibited.

1.0 Purpose

1.1 To ensure the quality of incoming raw material of Aerosil-200 (Colloidal Anhydrous Silica)

2.0 Scope

2.1 It is applicable for the analysis of Aerosil-200 (Colloidal Anhydrous Silica) in the quality control department.

3.0 Responsibility

3.1 Quality Control Manager
3.2 Assist. Q.C. Manager
3.3 Q.C Analyst

4.0 Abbreviations

4.1 SAP: Standard Analytical Procedure
4.2 QC: Quality control

5.0 Procedure

5.1 Equipment’s/Apparatus

a) Analytical balance
b) pH meter
c) Oven
d) Desiccator
e) Beaker
f) Test tubes
g) Pipettes
h) Platinum crucible
i) Furnace
j) Burner

5.2 Chemicals / Reagents

Chemicals:
1-Distilled Water
2-Hydrochloric acid
3-Sulphuric acid
4-Sodium carbonate

Reagents
1-Nitric acid 2M
2-Silver nitrate R2 solution
3-Chloride standard solution 5 ppm
4-Barium chloride 25% w/v

5.3 Physical Analysis

a) Test of Physical Form:
Check the sample and confirm its physical form; it should be light fine amorphous powder.

b) Test of Colour:
Confirm the colour of the material by comparing with reference sample; it should be white.

c) Test of Solubility:

• Water: Practically insoluble (10mg should be dissolved in more than 100ml)
• Mineral acids: Practically insoluble (10mg should be dissolved in more than 100ml)
• Hot alkali Hydroxide solution: Soluble (1g should dissolve in 10ml to 30ml)

d) Loss on Ignition:

Sample preparation

a) Dry the platinium crucible at 9000C for 30 minutes, cool in desiccator and weigh (P gm).
b) Spread uniformly the 0.2 g of substance in platinium crucible and weigh (Q gm).
c) Dry at 9000C for 2 hours temperatures till constant weight (F).

Observations

a) Weight of substance taken before process = Q – P = X g
b) Weight of substance taken after drying = F – P = Y g
c) 6.3.1.4.2.3 Difference = X – Y = L g

Calculations

% age of loss on Ignition = L/X x 100

It should not be more than 5.0 % of its weight.

e) Test of pH:

Shake 1 gm of sample with 30 ml of carbon dioxide free water. Then measure the pH with the help of previously calibrated pH meter. The pH of the suspension should be 3.5 to 5.5.

Limit Tests:

a) Test of chloride:

Sample Preparation

a) Heat 1 gm of substance in a water bath with 50 ml of water for 15 minutes with frequent shaking and then filter it off. Take 10 ml of filtrate and dilute to 15 ml with water.
b) Add to the resulting solution 1 ml of 2M nitric acid.
c) Pour the mixture as a single addition into 1 ml of silver nitrate R2.
d) Allow to stand for 5 minutes

Standard Preparation

a) Mix 10 ml chloride standard solution (5 ppm) with 5 ml of water.
b) Pour the mixture as a single addition into 1 ml of silver nitrate R2.
c) Allow to stand for 5 minutes.

Observation

Any opalescence produced in sample is not more intense than that of standard when viewed transversely against a black back ground.

Heavy Metals:

Sample Preparation:

a) Take 10 ml of solution A and dilute to 20 ml with water.
b) To 12 ml of resulting solution.

1.  Add 2 ml of acetate buffer pH 3.5 and mix.
2.  Add 1.2 ml of thioacetamide reagent. Mix immediately and allow to stands for two minutes.

Standard Preparation:

a) Mix 10 ml of 1ppm lead standard solution with 2 ml of above sample solution being examined.

1.  Add 2 ml of acetate buffer pH 3.5 and mix.
2.  Add 1.2 ml of thioacetamide reagent. Mix immediately and allow to stands for two minutes.

Blank:

a) Mix 10 ml of distilled water with 2 ml of prescribed solution.

1.  Add 2 ml of acetate buffer pH 3.5 and mix.
2.  Add 1.2 ml of thioacetamide reagent. Mix immediately and allow to stands for two minutes.

Observations:

Any brown colour produced in sample is not more intense than standard. The standard solution exhibits slightly brown colour when compared to blank.

6.0 Quality Record(s)/Form(s):

6.1 The following Quality Records shall be generated and managed in accordance with the Procedure for Control of Company Quality Records.

7.0 Reference:

BP 2020

8.0 List of recipients

Issued to	Issued on (Date / Signature)	Withdrawn on (Date / Signature)
Manager Quality Control
Manager Quality Assurance
Analyst (Work Station)