WELMARK PHARMACEUTICALS

Document Number
WM/QC/SAP-FP-053
STANDARD ANALYTICAL
Revision Number
0
PROCEDURE
Page No 1 of 6

Innovator
Title: SPASMODIC CARE TABLET SPECIFICATION

Specification and testing method OF SPASMIDIC tablet

Prepared by:....................................................

Waheed anjum

(Q.C Analyst)

Checked by:...................................................

Bilal ahmed

(Q.C senior analyst)

Approved by:..................................................:

Farmanullah

(Q.C manager)
 WELMARK PHARMACEUTICALS
Document Number
WM/QC/SAP-FP-053
STANDARD ANALYTICAL
Revision Number
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PROCEDURE
Page No 2 of 6

Innovator
Title: SPASMODIC CARE TABLET SPECIFICATION

Product Specification (core)

A)Monogram Reference No: INNOVATOR Specification

B) Description: white color OVAL Tablet and plaine on both side

C) Av.Weight: 340mg

D) Thickness: 4 mm—7mm

E) Hardness: NLT 5 Kg/cm

F) Friability: NMT 1%

G) Loss on Drying: NMT 5 % (GRANULE)

H) Disintegration time: NMT 15 minutes

I) Assay: phloroglucinol

trimethyle phloroglucinol 90 to 110 %

Composition:

Each sugar coated Tablet contains:

phloroglucinol 80mg/tablet

trimethyle phloroglucinol 80mg/tablet

 WELMARK PHARMACEUTICALS
Document Number
WM/QC/SAP-FP-053
STANDARD ANALYTICAL
Revision Number
0
PROCEDURE
Page No 3 of 6

Innovator
Title: SPASMODIC CARE TABLET SPECIFICATION

Product Specification (coated) `

a)Monogram Reference No: INNOVATOR Specification

Description:

white color OVAL brown color sugar coated Tablet and plaine on both side

c) Av.Weight : 560 mg ± 3%

d) Disintegration time: NMT 30 minutes

e) Assay: : phloroglucinol 80mg/tablet

trimethyle phloroglucinol 80mg/tablet

ASSAY: Mobile phase: Buffer: ACN (1:1) Preparation of Buffer:

Dissolve 1.33gm of potassium dihydrogen phosphate in 1000ml of water; adjust with phosphoric acid to a PH of 3.0
Diluent: Mobile phase Standard preparation: Dissolve accurately weighed 25mg of USP Phloroglucinol
Dihydrate & Trimethyl Phloroglucinol RS in 50ml volumetric flask and make volume with Diluent.

Pipette 1 ml of the solution in 25 ml volumetric flask and dilute with Diluent to volume Sample solution:

Weigh Sample equivalent to 25mg USP Phloroglucinol Dihydrate & Trimethyl Phloroglucinol RS into 50-ml
volumetric flask, dilute with Diluent, and sonicate for about 5 minutes. Filter the sample and Pipette 1
ml of the solution in 25 ml volumetric flask and dilute with Diluent to volume.

Chromatographic Condition: Mode: LC Column: 25cm× 4.6mm, packing L1

Column Temperature: Ambient

 WELMARK PHARMACEUTICALS
Document Number
WM/QC/SAP-FP-053
STANDARD ANALYTICAL
Revision Number
0
PROCEDURE
Page No 4 of 6

Innovator
Title: SPASMODIC CARE TABLET SPECIFICATION

Detector (UV): 265nm

Flow Rate: 1ml/min

Procedure: Calculate the percentage of Phloroglucinol Dihydrate & Trimethyl Phloroglucinol in the portion of
injection taken:

Result: (ru/rs) × (Cu/Cs) × 100

Ru=peak area response from sample solution

Rs= peak area response from standard solution

Cs=concentration of standard solution

Cu=concentration of sample solution

DISSOLUTION: Medium: 6.8 Phosphate buffer + 0.75% Brij + 1% Tween 80 in 1 Litre of water Volume: 900 ml
Apparatus: 02 RPM: 100 rpm Time: 60 minutes. Tolerance: NLT 75% (Q)

Chromatographic Condition: Same as directed in Assay.

Standard preparation: Dissolve accurately weighed 25mg of USP Phloroglucinol Dihydrate & Trimethyl
Phloroglucinol RS in 50ml volumetric flask and make volume with Diluent. Pipette 1 ml of the solution in
25 ml volumetric flask and dilute with Diluent to volume
 WELMARK PHARMACEUTICALS
Document Number
WM/QC/SAP-FP-053
STANDARD ANALYTICAL
Revision Number
0
PROCEDURE
Page No 5 of 6

Innovator
Title: SPASMODIC CARE TABLET SPECIFICATION

Procedure: Determine the amount of Phloroglucinol Dihydrate & Trimethyl Phloroglucinol dissolved. Take 20ml of
sample and filter it .Pippet 5ml from filtrate in 25ml flask and volume with mobile phase (diluent).
Result: (RU/RS) × (Cu/Cs) × 100

RU=peak response of sample solution

RS = peak response of standard solution

Cs=concentration of standard solution

Cu=concentration of sample solution

:
WELMARK PHARMACEUTICALS
Document Number
WM/QC/SAP-FP-053
STANDARD ANALYTICAL
Revision Number
0
PROCEDURE
Page No 6 of 6

Innovator
Title: SPASMODIC CARE TABLET SPECIFICATION