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a. pharmaceuticals (finished products) for all ... - Iraq Watch

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400 micron 52-78 , 500 micron 40-71630 micron 25-55 , 800 micron 7-26Determined by alpine type ALS 200 sieveSample wieght 10 gm,time 3 min.Depression 200 mm to 300 mm water angle repose 38.8Untapped apparent density 0.65-0.69gm/ml.Staffed density 0.74-0.77Should comply with BP80 specificationSpecification of the Raw material :Aluminium Hydroxide magnesium carbonate Co. dried gel .Ref. (Ext. pharmac. 27)Physical bulk density = 0.236gm/ml + 10%Tapped density (DIN satandard method = 0.347 + 10%with 1000 jolts)Microscopical examinations100 % over 3.3 micron3 % over 30 micronMean partical size = 5 micronsAnalytical specificationsAluminium oxide40-43 % proceed as directed in the assay <strong>for</strong> aluminium oxid under magaldrate USPXX page 456 (SDI analyticalstandard).Magnesium oxide.6-9 % proceed as directed <strong>for</strong> the assay of magnesium oxide under .Magaldrate USPXX page 456(SDI analytical satandard)pH of 4 % = 8.5 – 9.5Neutralization capacityM1 N/10 HCL per gm. min. 260Other requirments: It respond to the identification test under magaldrate and meet <strong>all</strong> the req.of microbial limit , chloride sulfate ,Arsenic and heavy metal under Aluminium Hydroxide dried gelCLOBETASOL PROPTONATEMICRONIZEDDescription : A white to creamy white odourless powderIdenticiation : Positive (I.R ,UV , HPLC )Solubility: Practic<strong>all</strong>y insolble in water , soluble 1 in 100 ml alcohol and 1 in 1000 of etherSoluble in acetone , dioxane chloro<strong>for</strong>m , dimethly sulfoxide .Melting point : 195 C + 3 CLoss on drying : not more than 1 % ( 3 hours at 105 C)Spacific optical rotation : + 100 to + 108( C= 1% w/v in dioxane )Light absorption ( at about 238 nm) 330-350 A ( 1% Tcm)Residue on ignition : not more than 0.2 %Related <strong>for</strong>eign steroids: not more than 3 % (TLC, HPLC)2- PACKAGING REQUIERMENTS & SPECIFICATIONSCODE NO DESCRIPTIONCapsulesCapsule Type Snap fit Capsule293 Empty gelatin capsule size 0 printed .294 Empty gelatin capsule size 1 printed295 Empty gelatin capsule size 0 elongatedN.B/1-5000 Capsules sample of each size is required <strong>for</strong> evaluation2- For exact color & printing sample will be sent to the buyerupon it’s request .3-Capsules to be protected by paper / polyethlene bags packedin a strong double corrugated carton .inner sides lined withtrays of styropore foam , outer sudes w<strong>all</strong> laminated with wax211 of 218

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