QUALITY ASSURANCE AND .

QUALITY CONTROL OF SEMISOLIDS

.1DEFINITION Semisolid dosage forms are dermatological products of semisolid consistency and applied to skin for therapeutic or protective action or cosmetic function.

Quality assurance and quality control of semisolids

Presented by

Ideal properties

a)Smooth texture b)Elegant in appearance c)Non dehydrating d)Non gritty e)non greasy and non staining f)non hygroscopic

PHYSICAL PROPERTIES

1.2.2 PHYSIOLOGICAL PROPERTIES: g)Non irritating h)Do not alter membrane / skin functioning i)Miscible with skin secretion j)Have low sensitization index 1.2.3 APPLICATION PROPERTIES: k)Easily applicable with efficient drug release. l)High aqueous washability.

STORAGE PROPERTIES
Climatic zones I Defini tion
Temp. climate

Storage/test conditions
21C + 2C and 45% RH + 5% RH

Example

Northern Europe, Canada

II

Mediter ranean & subtrop ical climate

Hot dry climate Hot, humid climate

25C + 2 C and 60% RH + 5% RH

Southern Europe, Japan, US

III IV

30C + 2C and 35% RH + 5% RH 30C + 2C and 75% RH + 5% RH

Egypt, Sudan Central Africa, South Pacific

RH = Relative Humidity

 QUALITY

ASSURANCE AND QUALITY CONTROL OF SEMISOLIDS

Parameters considers during evaluation of semisolids RAW MATERIAL SPECIFICATION INPROCESS CONTROL FINISHED PRODUCT SPECIFICATIONS

RAW MATERIAL SPECIFICATIONS

Sr. no Test

A. 1. 2. 3. 4. 5. 6.
7

Raw material name Structural formula, molecular weight Chemical name Item number Date of issue Date of superseded, if any, or new material Signature of writer
Signature of approval

B.
1. 2. 3. 4.

Samples
Safety requirement Sample plan and procedure Sample size and sample container to be use Preservation sample requirement

C.

Retest program Retesting schedule Reanalysis to be perform to assure identity, strength, quality and purity Specifications wherever applicable

1. 2.

D.

1.
2.

Description Solubility

3. a. b.

Identity
Specific chemical test Infrared absorption Ultraviolet absorption Melting range Congealing point

c.
d. e. f. g. 4.

Boiling point or range

Thin layer, paper, liquid or gas chromatoghraphy

Purity and quality

Specific quality tests ,particle size, crystallinity characteristics ,and polymorphic forms

b.

Specific purity tests , related degenerated products

5. 6.

Assay , calculated either on anhydrous or hydrous basis Microbial limit test, especially for raw materials from natural sources Test procedure

E.

1. 2.

Compendial USP or NF references Noncompendial, detailed analytical procedures, weights, dilutions, extraction, normality, reagent, instrumentation used and procedure, if any calculation

F.

Approved suppliers (list of prime suppliers and other approved alternative suppliers, if any)

INPROCESS CONTROLE

Processing of semisolids involves mixing, milling, heating and cooling of bulk products. Therefore, it is essential to develop in process control. Some important in process tests are as follows, 1. Complete solubilization (if applicable) 2. pH 3. Viscosity measurement 4. Uniformity of distribution of active ingredients 5. Physical stability 6.Measurement of density or specific gravity.

FINISHED PRODUCT SPECIFICATIONS

1. 2. a. b. c. d. e.

MICROBIAL TEST PHYSICAL TESTS viscocity measurement texture analysis ointment flow characteristics ointment consistency gel strength fiavour release sachet or tube extrusion measurement

CHEMICAL TESTS
Chemical potency test Content uniformity test Ph measurement