Тендер - Продажа микрокристаллическая целлюлоза+натрия карбоксиметилцеллюлоза 811Р (25 кг). В наличие на складе в Белгороде №278419530

Описание Заказчик Лоты

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Наименование продукта: Целлюлоза микрокристаллическая + карбоксиметилцеллюлоза натрия 811P (25 кг)

Производитель: Samarpit (Индия)

Дата производства: 27.06.2024

Дата истечения срока годности: 26.06.2029

Сертификат и методики анализа приложены.

В наличие на складе.

PS_COA_of_Microcrystalline_cellulose_+_Carboxy_methyl_cellulose_sodium

®

SAMARPIT GROUP

BLOCK B (6 TO 12), SECOND FLOOR, AMRAPALI MALL AMBLI-BOPAL ,

AHMEDABAD▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть, GUJARAT. Email: ▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть

Devoted for Life

CERTIFICATE OF ANALYSIS

Microcrystalline Cellulose+ Carboxy Manufacturing Date

methyl cellulose sodium 811P

Product

Name

27/06/2024

Batch No.

SG/24-25/1078

Expiry Date

26/06/2029

Grade

USP/EP

Batch size

5000kg

Sr. No.

1

TES T

Description

2

3

Solubility (copper tetramine solution)

Identification

A)

B)

C)

Assay for CMC-Na(ldent.D,ph.Eur)

4

5

6

7

8

9

10

11

SPECIFICATION

It is an attrited mixture of MCC and

CMC-Na. by high shear dispersing in

water the almost fine granular

odourless powder performs a gel with

thixotropic properties.

Should pass test

Should pass test

RESUL T

A White powder

Passes

Passes

Should pass test

Should pass test

11.3%-18.8%

Passes

Passes

15.04%

4.4%

7.01

Heavy metal

Max 0.001%

Loss on drying

Max 8.0%

6.0- 8.0

pH

Sulphated ash/Residue on ignition

Max 5.0%

Microbial contamination

NMT 103 cfu/g

Total viable aerobic count

NMT 102 cfu/g

Total molds & yeast count

Absent in lg

E.coli, staph.aureus, Pseudomonas

aeruginosa

Salmonella

Absent in 10g

Viscosity 2.6%

▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открытьcps

Particle size (retained on air jet sieve Max 3.0%

>2S0µm(60mesh)

Storage Condition: Store at room temperature.

The material complies as per EP/ USP pharmacopeia.

90 cfu/g

Absent

Absent

3279cps

0.6%

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Compiled by QC

Checked by QC

Approved by QA

Khushbu Patel

QC Specialist

Cheshta Jaitely

Manager QC

Ravleen Kaur

Manager QA

Date:

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2�/o G/24

Registered Address:

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Date:

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9_-+/ 011l·u-1

S-201, AAROHI CREST, GALA GYMKHANA ROAD, SOUTH BOPAL, AHMEDABAD▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть, GUJARAT

J

MOA_of_MICROCRYSTALLINE_CELLULOSE_CARBOXYMETHYLCELLULOSE_SODIUM_MCC

SAMARPIT GROUP

BLOCK B (6 TO 12), SECOND FLOOR, AMRAPALI MALL AMBLI-BOPAL,

AHMEDABAD –▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть, GUJARAT. Email: ▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть

STANDARD TEST PROCEDURE

SR

No

1

Test parameter

Standard testing procedure

Description/

Appearance

It is an attrited mixture of MCC and CMC-Na. By high shear

dispersing in water the almost fine granular odourless powder

performs a gel with thixotropic properties.

2

Identification

3

Viscosity (911):

Mix 6 g with 300 mL of water in a blender at 18,000 rpm for 5

minutes. Acceptance criteria: a white, opaque, dispersion is

produced which does not settle on standing.

Add several drops of the dispersion obtained in Identification

test A to a solution of aluminium chloride (1 in 10).

Acceptance criteria: each drop forms a white, opaque globule

which does not disperse on standing.

Add 3 mL of iodine TS to the dispersion obtained in

Identification test A. Acceptance criteria: No blue or purplish

blue color is produced

Determine the amount of Microcrystalline Cellulose and

Carboxymethylcellulose Sodium needed to prepare 600 g of a

suitable dispersion, calculated on the dried basis. Transfer an

accurately weighed amount of water to a 1000 mL blender bowl.

Begin stirring with an 18,000 rpm blender at a reduced speed

obtained by adjusting the voltage to 30 volts by means of a

suitable transformer, and immediately add the accurately

weighed portion of Microcrystalline Cellulose and

Carboxymethylcellulose Sodium, taking care to avoid contacting

the sides of the bowl with the powder. Continue stirring at this

speed for 15 seconds following the addition of the powder ,

then increase the transformer setting to 115 volts, and mix for 2

minutes, accurately timed, at 18,000 rpm. Stop the blender, and

lower the appropriate spindle of a suitable rotational viscometer

into the dispersion. Thirty seconds after cessation of mixing,

start the viscometer, and determine the viscosity using the

appropriate spindle to obtain a scale reading between 10% and

90% of full —scale at a speed of 20 rpm. Determine the scale

Registered Address:

S-201, AAROHI CREST, GALA GYMKHANA ROAD, SOUTH BOPAL, AHMEDABAD –▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть, GUJARAT

1

Reference

MICROCRYSTALLINE CELLULOSE & CARBOXYMETHYLCELLULOSE SODIUM

MCC 811

USP/NF,Ph Eur.

Page No.

1 of 4

Page

Material Name

SAMARPIT GROUP

BLOCK B (6 TO 12), SECOND FLOOR, AMRAPALI MALL AMBLI-BOPAL,

AHMEDABAD –▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть, GUJARAT. Email: ▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть

pH:(791)

5

Loss on Drying (731):

6

Residue on

Ignition(281)

7

Heavy metals Method

11(231):

Page

2

4

reading after 30 seconds of rotation, and calculate the viscosity,

in centipoises, by multiplying the scale reading by the constant

for the spindle used at 20 rpm.

Acceptance criteria : LIMIT :GRADE MCC 811 ▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открытьCPS)

2.6% SOLIDS AT 25 °C BROOKFIELD /LVF

GRADE MCC 811

Between 6.0 and 8.0 determined on the dispersion prepared in

the test for Viscosity.

Tare the glass stoppered, shallow weighing bottle that has been

dried for 30 minutes under the same condition to be employed

in the determination .Mix and accurately weigh 1 gm of test

substance. Distribute the substance as evenly as practicable to a

depth of about 5mm generally .Place the loaded bottle in the

drying chamber, removing the stopper and leaving it also in the

chamber .Dry it at 105°c ± 2 °c for 3 hours .Upon opening the

chamber, close the bottle promptly and allow it to come to

room temperature in a desiccator before weighing.

Acceptance criteria: It loses NMT 8.0 % of its weight or some

other lower percentage, or is within a percentage range, as

specified in the labelling.

Ignite a crucible at 600°c ± 50°c for 30 minutes, cool the crucible

in a desiccator and weigh it accurately .Weigh accurately 1 gm of

the substance in the crucible .Moisten the sample with a 1 ml of

sulphuric acid ,then heat gently at a temperature as low as

practicable un till the sample is thoroughly charred .Cool , then

moisten the residue with 1 ml of sulphuric acid :heat gently until

the white fumes are no longer evolved and ignite at 600°c ± 50°c

un till the residue is completely incinerated .Ensure the flame

are not produced at any time during procedure. Cool the

crucible in a desiccator weigh accurately, and calculate the

percentage of residue.

Acceptance criteria: Not more than 5.0%.

pH 3.5 Acetate buffer: Dissolve 25 gm of ammonium acetate in

25ml of water and add 38 ml of 6 N hydrochloric acid. Adjust, if

necessary, with 6 N ammonium hydroxide or 6 N hydrochloric

acid to pH 3.5, dilute with water to 100m1 and mix.

Registered Address:

S-201, AAROHI CREST, GALA GYMKHANA ROAD, SOUTH BOPAL, AHMEDABAD –▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть, GUJARAT

SAMARPIT GROUP

BLOCK B (6 TO 12), SECOND FLOOR, AMRAPALI MALL AMBLI-BOPAL,

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Standard preparation: In to a 50 ml color comparison tube pipet

4 ml of standard lead solution (10 [ig of Pb), and add 10 ml of 6

N hydrochloric acid.

Test Preparation: Transfer the 4 gm of sample to a suitable

crucible .Add sufficient amount of sulphuric acid to wet the

substance, and carefully ignite at low temperature until

thoroughly charred crucible may be loosely covered with the

suitable lid during charring. Add to the carbonized mass 2m1 of

nitric acid and 5 drops of sulphuric acid, and heat cautiously

until white fumes no longer are evolved. Ignite preferably in a

muffle furnace at 500°c to 600 c. Until the carbon is completely

burned of. If carbon remains, allow the residue to cool, add a

few drops of sulphuric acid, evaporate and ignite again. Cool add

5 ml of 6N hydrochloric acid, cover and digest on water bath for

10 min. Cool and quantitatively transfer the solution to a test

tube. Rinse the crucible with second 5m1 portion of 6N

hydrochloric acid and transfer the rising to the test tube.

Registered Address:

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Page

Procedure: To each of the three tube containing the standard

preparation, the test preparation and monitor preparation, add

cautiously and drop wise ammonium hydroxide to a pH 9. Cool

and adjust with glacial acetic acid, added drop wise to a pH of 8,

then add 0.5m1 in excess, Using a pH meter, check the pH and

adjust if necessary with 1N acetic acid or 6 N ammonium

hydroxide to a pH between 3.0 to 4.0. Filter if necessary,

washing the filter with few ml of water, into a 50m1 of color

comparison tube and dilute with water to 40m1. Add 2 ml of pH

3.5 Acetate buffer, then add 1.2 ml of thioacetamide glycerine

base TS, dilute to 50m1, mix allow to stand for 2 min and view

downwards over the white surface.

3

Monitor preparation: Pipette 4 ml of standard lead solution (10

p.g of Pb) in to a crucible identical to that used in the test

preparation and containing a 0.4 g of substance. Evaporate on

steam bath to dryness. Ignite at the same in the muffle furnace

and under the same condition use for test preparation, cool and

quantitatively transfer to a test tube. Rinse the crucible with a

second 5m1 portion of 6N Hydrochloric acid and transfer the

rinsing to the test tube.

SAMARPIT GROUP

BLOCK B (6 TO 12), SECOND FLOOR, AMRAPALI MALL AMBLI-BOPAL,

AHMEDABAD –▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть, GUJARAT. Email: ▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть

Observation: The color of the solution from the test preparation

is not darker than that of the solution from the standard

preparation, and the color of the solution from the monitor

preparation is equal to or darker than that of solution from the

standard preparation

8

Acceptance criteria: Not more than 0.001%

Assay for

Transfer about 2 -g of microcrystalline cellulose and

carboxymethylcellulose Carboxymethylcellulose Sodium, accurately weighed, to a glassSodium stoppered, 250-mL conical flask. Add 75 mL of glacial acetic acid,

attach a condenser, and reflux for 2 hours. Cool, transfer the

mixture to a 250 mL beaker with the aid of small volumes of

glacial acetic acid, and titrate with 0.1 N perchloric acid in

dioxane VS, determining the endpoint potentiometrically. Each

mL of 0.1N perchloric acid is equivalent to 29.6 mg of

carboxymethylcellulose Sodium.

Microbial limit: (61)

10

Particle Size

Distribution :

Page

4

9

Acceptance criteria :Limit: MCC 811 (11.3-18.3)

The total aerobic microbial count does not exceed 1000 cfu per

gm, the total combined molds and yeasts count does not exceed

100 cfu per gm, and it meets the requirement a of the tests for

absence of Staphylcouus oureus and Pseudomonas aeruginosa

and for absence of Escherichia coli and Salmonella species.

Sieve Analysis: Take 10 gm sample

Retension on 60 mesh- Not more than 3%

Registered Address:

S-201, AAROHI CREST, GALA GYMKHANA ROAD, SOUTH BOPAL, AHMEDABAD –▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒▒ - открыть, GUJARAT