Active Pharma Ingredients APIs

PARAMETERS

SPECIFICATION

TEST METHOD

PHYSICAL CHARACTERISTIC

Colour

Light brown to brown

Visual

Appearance

Powder

Visual

Flavor

Characteristics

QC/STP/SEN/01

Odor

Characteristics

QC/STP/SEN/01

identification

Positive by TLC

USP

ANALYTICAL ASSAY

HERB Extraction Ratio

18:1

Loss on drying

NMT 5.0%

USP<731>

Solvent use

Methanol

Residual solvent

Methanol NMT 3000 ppm

USP<467>

Particle Size

NLT 95% through 40 mesh

USP<786>

TESTS

SPECIFICATIONS

RESULTS

Descrption

White crystalline powder

White crystalline powder

Solubility

Freely soluble in water

Complies.

Identification

A)     Infrared absorption

B)      Test for chloride

C)      Retention time

To comply with usp

To comply with usp

To comply with usp

Complies.

Complies.

Complies.

Specific optical rotation

(on dry basis)

+70⁰ to +73⁰

+71.52⁰

pH

3.0 to 5.0

4.27

Loss on drying

Not more than 1.0%

0.25%

Residue on ignition

Not more than 0.1%

0.05%

Sr.No.

Parameters

Standard value

Observed values

1.0

Physical parameters:-

1.1

Descrption

White crystalline powder or flake crystal

Complies.

1.2

Identification

1.2.1

IR identification

The IR spectrum of sample shold be concordant with the IR spectrum of the MSM working standard

Complies.

1.2.2

Retention time

The retention time of sample assay peak corresponds to the standard peak .

Complies.

1.3

solubility

Freely soluble in water

Complies.

1.4

Water content

NMT 0.1 % w/w

0.05% w/w

1.5

Melting point

108.50 to 110.50^oc

109 to 110⁰c.