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Sr. No. Product Active ingredient Batches Batches on stability Stability status Product availability Remarks
taken
1 Calcipotriol 0.005 % Calcipotriol 4 batches acclerated staibility batches mfd on 16.01.09 (one batch) & 06.03.09 ( two batches ) acclerated staibility study is RDC01 trial batches
cream monhydrate0.005% study is completed. completed.perservative chlorocresol resuts pending from QC.Product is stable, no remarkable prepared and
changes in cream.degradation report to be given by QC this week formulation to be
optimized after getting
assay result from QC for
trial batch.. results of
trial batch is 97.11 %

Calcipotriol Trial batches manufactured


monhydrate0.005 on 03/10/08 and assay of
Calcipotriol (0.005% ) + % calcipotriiiol received from formulation to be
betamethasone +betamethasone trial batch prepared ( RDBC01)and formulation to be optimized after getting assay result from QC QC on 02/01/09. on the optimized after getting
Dipropionate (0.05%) dipropionate RDBC01, for trial batch . results of trial batch is found OK,first stability batch (RDBC02) made on 30/11/09. basis of .Calcipotriol assay assay result from QC for
2 cream 0.05% 2 batch RDBC02 results awiating from QC. obtained trial batch..

sample results pending from QC. Bulk to be manufuactured for stability.formula is ready for
3 zinc oxide cream\ paste zinc oxide 20 % 3 BATCH stability batches

Note: trial batches of isotretinoin gel & ketoconazole cream is going on for optimization

GEL

WORK UNDER DEVELOPMENT


1 Formula optimization of Tacrolimus ointment (tacrolimus 0.03 % ) ,the trials is in process
2 Formula optimization of lidocane gel (lidocane2%). The trials is in process
3 hand sanitizer with aloe vera and with out aloe vera transparent gel formulation optimization going on.

Sr. No. Product Active ingredient Batches taken Batches Stability status Product availability Remarks
on
stability
1 Trewor Tretinoin Cream USP 6 month stability 6 month stability completed . liquidfication & separation of cream was observed ,i.e.. plain liquid
cream- old 0.05%w/w &0.025% completed . cream in upper part of the tube( cap part )and yellowish liquid cream in the bottom part of the tube
formula ( ( crimping part)
having 0.2%
of xanthan
gum.

2 Trewor Tretinoin Cream USP 6 month stability the batch to compare with present old formula ( old composition) ,No separation was observed.)one
cream- new 0.05%w/w &0.025% completed . batch mfd & kept for stability studies
formula Accelerated samples (40˚ c), other samples 30 &25˚ c, was samples analyzed . There is no
having 0.5 % remarkable fall in the assay & results are ok..physical appearance ok, samples kept for checking
of xanthan physical appearance after 9 months ,9 month observation is ok
gum.

3 Methyl paraben sodium 3 RDSG07, stablity completed product ready,dossier is ready with old formula ,new found to be not stable,new materials to be
0.1% 08,09 used in the fresh batch & study.
lubricating propyl paraben sodium
jelly 0.04%
4 Ibuprofen gel Ibuprofen 5% ,Menthol 3 batches RDI01,R stablity completed stability summary is avaiting from QC
5% 3%, alcohol 80% DI02,RD0
3
5 Minoxidil gel Minoxidil 2%-, 3 batches MG01,M stablity completed, product ready
2%- G02,MG0 dossier is ready
alcohol 40 % (overage 3
6 5 %)
Minoxidil gel Minoxidil 3% 3 batches MG01, stablity completed product ready
3%. alcohol 40 MG02 dossier is ready
% (overage 5 %) MG03.
7 Minoxidil gel Minoxidil 5%- 3 batches MF01,MF stablity completed product ready
5% alcohol 40 02,MF03 dossier is ready
%( overage 5 %)
9 Diclofence Diclofence sodium 1% 3 batches RDD02,0 3 Batches mfd. &
+methol+met +methol 5%+methyl 3,04 samples given for
hyl salicylate+ salicylate 5% + vit-E analysis to qc ,we
vit-E gel 0.5% are awaiting the final
( diclcofence results & summary
with vit E gel) result report from qc .

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