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Avicel 102 (Microcrystalline Cellulose) Raw Material SAP

Pharmaceutical excipients Avicel 102 (Microcrystalline Cellulose) Raw Material according to the International Pharmaceutical Excipient Council (IPEC), excipients are the process aids or any substances other than the active pharmaceutical ingredient that are included in pharmaceutical dosage forms. The functionalities of excipient are to impart weight, consistency, and volume which allow accuracy of dose, improve solubility, and in the end increase stability. It can also be proposed to enhance bioavailability, modifying drug release and used in product quick identification, increase patient acceptability, and facilitate dosage form design.

Excipients classified as:
Primary excipients: diluents (filler), binders (adhesives), disintegrants, lubricants, antiadhesives, glidants. 

Complete Testing Avicel 102 (Microcrystalline Cellulose) Raw Material follow STANDARD ANALYTICAL PROCEDURE

 

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
2

 

Written by Checked by Approved by Authorized by
  

Analyst

  

Quality Control Manager

  

Quality Assurance Manager

  

General Manager Plant

Date: Date: Date: Date:

1.0 Purpose

1.1 To ensure the quality of incoming raw material of Avicel 102 (Microcrystalline Cellulose).

2.0 Scope

2.1 It is applicable for the analysis of Avicel 102 (Microcrystalline Cellulose) 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/Apparatus

a) Analytical balance
b) Glassware
c) Loss on drying bottle
d) Desiccator
e) Oven
f) pH meter
g) Conductivity meter

5.2 Chemicals/Reagents

Chemicals

  • Distilled water
  • Carbon dioxide free water
  • Acetone
  • Toluene
  • Ethanol (96%)
  • Toluene
  • Peroxide-free ether

Reagents

  • Iodine 0.05 M
  • Iodinated ZnCl2 Solution
  • Dilute Hydrochloric Acid
  • Dilute Sulphuric Acid
  • 50% Sodium Hydroxide

5.3 Physical Analysis

Test of Physical Form:

Check the sample and confirm its physical form; it should be fine or granular powder, odorless.

b) Test of Colour:

Confirm the colour of the material by comparing with reference sample; It should be white or almost white.

Test of Solubility:

  • Water: Practically insoluble
  • Acetone: Practically insoluble
  • Ethanol (96%): Practically insoluble
  • Toluene: Practically insoluble
  • Dilute acids: Practically insoluble
  • 50g/L soln of NaOH: Practically insoluble

d) pH:

Shake 5 g with 40 ml of carbon dioxide free water for 20 minutes.
The pH of supernatant layer is 5.0 – 7.5.

e) Loss on drying:

Method

a) Dry the loss on drying bottle with cover at 125oC for 30 minutes, cool in desiccator and weigh (P gm).
b) Spread uniformly 1 gm of the substance in Loss on drying bottle and weigh (Q gm)
c) Dry at 105oC for three hours and then weigh (F gm).

Observations

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

Calculations
% age of loss on drying = L/X x 100
It should be not more than 7%.

h) Conductivity:

The conductivity of the test solution (obtained in the test for pH) does not exceed the conductivity of the water by more than 75 μS/cm- 1.

i) Ether-soluble substances:

Prepare a column using 10.0 g in a tube about 20 mm in internal diameter. Pass 50 ml of peroxide-free ether R through the column. Evaporate the eluate to dryness. The residue weighs not more than 5.0 mg (0.05 per cent).

Limit Tests:

Starch:

Shake 0.1 g with 90 ml of water, filter while hot & add 0.2 ml of 0.05 M iodine. No blue colour is produced.

Water soluble substances:

Shake 5 g with 80 ml of water, filter& evaporate to dryness at 1050C. The residue weighs no more than 12.5mg 0.25%.

5.4 Chemical Analysis:

Identification of Avicel:

Place about 10 mg on a watch glass & disperse in 2 ml of iodinated zinc chloride solution the powder becomes violet blue.

Microbial contamination

Total viable aerobic count not more than 103 micro-organisms per gram and with a limit for fungi of 102 per gram, determined by plate-count. It complies with the tests for Escherichia coli, for Pseudomonas aeruginosa, for Staphylococcus aureus and for Salmonella.

MCC Type Particle size (micron) Utilization

PH 101 50: It is most widely used for direct compression tableting, for wet granulation, for spherizations, and in capsule filling processes

PH 102 100: It is used as the PH-101, but its larger particle size improves the flow of fine powders

PH 103 50 It has the same particle size as PH-101 with lower moisture content (3%), so it is used for moisture-sensitive pharmaceutical active ingredients

PH 105 Less than 50 It is the most compressible of the PH products owing the smallest particle size. Well known as excipient for direct compression for granular or crystalline materials. When mixed with PH-101 or PH-102, specific flow and compression characteristics will be obtained. It has applications in roller compaction

PH 112 100 It has the same particle size as PH-102. It has lower moisture content (1.5%). It is used for high moisture-sensitive pharmaceutical active ingredients

PH 113 50 It has the same particle size as PH-101. It has lower moisture content (1.5%). It is used for high moisture-sensitive pharmaceutical active ingredients

PH 200 180 It has a large particle size with increased flowability. It is used to reduce weight variation and to improve content uniformity in direct compression formulations and in wet granulation formulations

PH 301 50 It has the same particle size as PH-101 but is denser providing more flowability and tablet weight uniformity. Useful for making smaller tablets and in capsule filling excipient

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)

 

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