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05. Technical Data: [For TD of Docusate Sodium 120 mg Tablet] Composition / Formula: Each film coated tablet contains
ID-Code New Active Active Ingredient Docusate Sodium Specificati on USP Quantity per Tablet 120.000 mg Overage --

OEG0029 OEG0032 OEG0037 OEG0042 OEG0142 OEG0018 OEG0047 OEG0031 OEG0167

Excipients: Lactose Maize Starch Microcrystalline Cellulose (Avicel PH 101) Polyvinyl Pyrrolidone (Povidone K-30) Crospovidone Colloidal Anhydrous Silica Purified Talc Magnesium Stearate *Purified Water

BP BP BP BP BP BP BP BP BP

44.500 mg 20.000 mg 50.000 mg 5.000 mg 5.000 mg 3.000 mg 1.500 mg 1.000 mg 50.000 mg

Coating Materials: OCM0011 Mastercote White FA 0961 G Ph. Gr. 7.700 mg OCG0011 Spectrablend Clear SB 9043 Ph. Gr. 5.300 mg OEG0167 *Purified Water BP 40.400 mg OEG0047 Purified Talc BP 750.000 mcg OCG0002 Carnauba Wax BP 125.000 mcg * Used as solvent & will not appear in finished product. (b) Manufacturing Instructions: i) Weigh and take in to a SS Mass Mixer the required quantity of Docusate Sodium , Maize Starch, Microcrystalline Cellulose (Avicel PH 101), Lactose, Povidone K-30 by sieving through # 20 mesh SS Screen. ii) Dry mix the sieved materials of step-i for 15 minutes in a Planetary mass mixer.

iii) Prepare Maize Starch paste with required quantity of Purified Water. Keep the temp. of maize
starch paste 45oC 50 oC before adding in dry mixing mass. iv) Add Maize Starch paste slowly to the contents in Planetary mass mixer and mix for 10-15 minutes to produce mass effective granules. v) Take the contents of wet granules from Planetary mass mixer bowel to the bowel of FBD. vi) Dry the wet granules at 50oC to achieve desired Loss on drying. vii) Reduce the granules size through multi mill by 1.5 mm pore size of SS screen & collect the granules in the suitable blender. viii) Blend the granules by adding Crospovidone, Colloidal Anhydrous Silica ,Magnesium Stearate and Purified talc for 15 minutes. ix) Send sample to QC Section for analysis. x) Compress the granules using specified die & punch through Tablet Press Machine after getting QC test results and approval from QA Department. xi) Send sample of compress tablet to QC Section for analysis.

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xii) Prepare coating solution with the coating materials and coat the core tablet after getting QC test results and approval from QA Department. xiii) Send sample of coated tablet to QC Section for analysis. xiv) Blister pack the Tablet after getting QC teat results & approval from QA Department. (c) Control data of active ingredient and included Pharmacopoeia: Docusate Sodium USP (d) Pharmacopoeial References or Control Data for other constituents: As that mentioned in the composition / formula. (e) Control data for finished product: Description : White color round, shallow bi-convex film coated tablet with single dividing line. Identification : Must comply with the +V test for Docusate Sodium USP. Weight of content / tablet : 255 mg (approximately) Uniformity of weight : Maximum two tablets out of twenty shall deviate 5 % of Average Weight & none shall deviated 10% of Average Weight. Disintegration Time : Not more than 15 minutes. Dissolution Rate : Not Less than 75% of the labeled claim amount of Docusate Sodium. Assay : 90 to 110 % of the labeled claim amount of Docusate Sodium : To be submitted during inclusion

(f) Stability study data of finished product (g) Proposed Shelf Life

: 2 years from the date of manufacturing