M .L.A .

Industries ( Pharma Division)

'i1-.1!230,HARSH NAGA R , KANPUR,Tcl. : (0512)-2555292
Website:www.mlagroup.. com. E·rnajl;saJes@ml<lgroup.CQnl

(Drug License No. 11/2018 )

(Food Safety & Drug A iJministration - Govt. of Uttar Pradesh)

CERTIFICATE OF ANALYSIS

~~~~~~~~R ~ ~~;~~i,~~PS;~~~;E I ~~~~~E ____\~~mE~ ____ . -----------.- .---- - ----~

F~:t:~7-~G~f}ij~~~~·~~1_~ ---·--_==~i-~~~~~;;~~~7J~~~1~om-~f.Q. ___~~=~_=-=--==J

IPRoriRTY- ---···---.---U-N- IT-:- - - - -S-PF 'S------------~---Es-
- -.C-I-F-IC-A-TH-)N- T-· VA'LllE-

IDes~-Pt-
ri-I()n--·----f-­
I · A \\ihite, very fine, tight POWdel~grcasy-to-ihc-tOl;c~--j-cO;;1PfTcs-\~~h EP --'-­
! solul;ility practic:lll y-i~ solubic in water an~iT~ etham;C ------- · ! -C mpt-;e-~~;~h-E-r)--l
r- -·------ -'-- --·--- --·-- - ---+-.- - --.-- -...- . ---.. -.-.- ----. . ---·--"- - -1
i
I
,
Ide.l1tifica.fion
f
!
A. fr~ezing point not lower than 53 cc.
B. acid val ue of the fatty acids is 195 to 21 0
C. passes
A - 58"C.
B - 205
C - P?l SS'~S
.

D. 1 rnl of solution S gives the reaction of magncsi UI11) i D - Pass's

Acidity or 1. Net more than 0.5 tn! of .( m he! Qr 0.0 I M :sodium --------1- - - Passes
i alkalinity. I: hydroxide is required to change the cotour of the . I ~'
i indicator. I
II-'~_:_~~_%_.:_-
~ds
e_ _ _ _ ~--- ~------­-+!--------~-:~~~-~~~~---=~:~ ------·--- ----r
!¥ 0
.:~'~ - -­
------------+- --_.._ --- --- . . ' ¥ M_ """'~ _

I
Cadmium _ _ _----iI_ _
P_pl_TI___ _.___________N_N1T 3 ppm ._ -_ 0.86
._-_...__._---­
- - -:--
Lead ppm I NMT 10 ppm
_ •• _ _ _ _ _ .M •• _ _ •• _ _ • _ _

4.60
I--N-ic-k-,c-,I-----------~r·--p-p-In-,---+I----------­
_ ••• M .
.­
Nt\!1T 5 ppm 3.5
.­ ._._----­
+'
I
I Loss on drying 1 N MT6.0%
% 3.60 .
l---M-i-c-rO- b- i-a-l - -""-- - -lf CFlT/g --- I .
TAMC: acceptal1ce criterion 103 CFU/g
.- ­
contamination TYMC : acceptallee criterion 102 CFU/g Passes
i E. .eli " Sa lmonella-
. Absent
.­ _ ,
~-------------~-------~-----­
ASSAY %
Stearic acid and
4 .0
%
~ 5,(1

Stearic Acid In the fai l)f acid 11'action Ininium 40.0 % i

--. ~

1
i _•..-.. _. __
4.62 ._---

i Palmitic acid Sum of steari \.: acid and palmittic. acid in the fatty acid Com.plies with EP
L - ___ _ _ __ __ _ _ _ _- L_ _ _ _ _ _ _ _ _ _ _fra
_ _L ­ __ction ____ 90.0
__ __minium ___ %_ _ _
"