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Tag Archive : Microcrystalline cellulose

Hydroxyethy Cellulose

Microcrystalline Cellulose 102 Certificate of Analysis

CERTIFICATE  OF  ANALYSIS
Product:Microcrystalline Cellulose 102
Batch  No. 161120 REP   DATE NOV.27,2016
Specifications 20kg/bag MFG   DATE NOV.21,2016
Quantity 1000kg EXP   DATE NOV.20,2018
Tests Standard USP35 Examinations
Identification Positive Positive
PH 5.0-7.0 6.2
Ether-soluble Matter(%) ≤0.05 0.03
Water-soluble Matter(%) ≤0.25 0.15
Conductivity ≤75 35
Heavy Metals ≤10PPM <10PPM
Residue on Ignition(%) ≤0.1 0.09
Loss on Drying(%)

 

 

≤7.0 3.6
Bulk Density(G) gm/ml 0.28-0.38 0.35
Particle Size:                          +60Mesh(%)                        +200Mesh(%) ≤8%                                       ≥45% Complies
Microbial limits Complies Conforms
Conclusion It conforms to USP35.
Hydroxyethy Cellulose

Microcrystalline Cellulose PH101 USP35-NF30

 

Microcrystalline Cellulose PH101  USP35-NF30

BATCH NUMBER 20170405 TEST DATE Apr.06,2017
QUANTITY 3400kg MANUFACTURE DATE Apr.05,2017
PACKING 25kg/bag EXPIRY DATE Apr.04,2019

 

TEST ITEMS SPECIFICATION RESULTS
Appearance White or almost white,fine or granular powder. Conform
Identification A Conform Conform
Identification B The degree of Polymerization≤350 207
Granulometry          Remains  60mesh≤1%

Remains  200mesh≤30%

0.2%

9.4%

Conductivity   ≤75us/cm 42us/cm
PH value 5.0-7.5 6.3
Loss on drying ≤7.0% 3.1%
Residue on ignition ≤0.10% 0.03%
Water Soluble Substances ≤0.25% 0.12%
Ether-Soluble Substances ≤0.05% 0.03%
Heavy metal ≤0.001% <0.001%
Microbial limits    
TAMC ≤1000cfu/g 90CFU/g
TYMC ≤100cfu/g 10CFU/g
Escherichia coli Absent Absent
Salmonella species Absent Absent
Staphylococcus aureus Absent Absent
Pseudomonas aeruginosa Absent Absent
Conclusion: Conform

 

 

Hydroxyethy Cellulose

Microcrystalline Cellulose 101

CERTIFICATE  OF  ANALYSIS  
ProductMicrocrystalline Cellulose 101  
Batch  No. 170395 REP   DATE MAR.24,2017
Specifications 20kg/bag MFG   DATE MAR.18,2017
Quantity 2000kg EXP   DATE MAR.17,2019
Tests Standard USP35 Examinations
Identification Positive Positive
PH 5.0-7.5 6.49
Ether-soluble Matter(%) 0.05 0.03
Water-soluble Matter(%) 0.25 0.16
Conductivity(µS/cm) 75 19.5
Heavy Metals 10PPM 10PPM
Residue on Ignition(%) 0.1 0.09
Loss on Drying(%) 7.0 4.7
Bulk Density(G) gm/ml 0.28-0.38 0.36
Particle Size:                          +60Mesh(%)                        +200Mesh(%) 1%                                       30% No remains
3.00%
Microbial limits Complies Conforms
Hydroxyethy Cellulose

What is Microcrystalline cellulose (C6H10O5)n

Microcrystalline cellulose (C6H10O5)n is refined wood pulp. It is a white, free-flowing powder. Chemically, it is an inert substance, is not degraded during digestion and has no appreciable absorption. In large quantities it provides dietary bulk and may lead to a laxative effect.

Microcrystalline cellulose is a commonly used excipient in the pharmaceutical industry. It has excellent compressibility properties and is used in solid dose forms, such as tablets. Tablets can be formed that are hard, but dissolve quickly. Microcrystalline cellulose is the same as cellulose, except that it meets USP standards.

It is also found in many processed food products, and may be used as an anti-caking agent, stabilizer, texture modifier, or suspending agent among other uses. According to the Select Committee on GRAS Substances, microcrystalline cellulose is generally regarded as safe when used in normal quantities.

Hydroxyethy Cellulose

Microcrystalline cellulose Details

Microcrystalline cellulose

Prepared at the 49th JECFA (1997)
superseding specifications prepared at the 46th JECFA (1996),
published in FNP 52 Addendum 4 (1996)

SYNONYMS Cellulose gel, INS No. 460
DEFINITION Microcrystalline cellulose is a purified, partially depolymerized cellulose prepared by treating alpha-cellulose, obtained as a pulp from fibrous plant material, with mineral acids. The degree of polymerization is typically less than 400. Not more than 10% of the material has a particle size of less than 5聽m聽m.
Chemical names Cellulose
C.A.S. number 9004-34-6
Chemical formula (C6H10O5)n
Assay Not less than 97% of carbohydrate calculated as cellulose on the dried basis
DESCRIPTION Fine, white or almost white, odourless, free flowing crystalline powder
FUNCTIONAL USES Emulsifier, stabilizer, anticaking and dispersing agent
CHARACTERISTICS
IDENTIFICATION
Solubility Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
Infrared absorption The infrared absorption spectrum of a potassium bromide dispersion of the sample corresponds to the infrared spectrum in the Appendix
PURITY
Loss on drying Not more than 7.0% (105 掳, 3h)
pH 5.0 – 7.5
Shake 5 g of the sample with 40 ml of water for 20 min and centrifuge. Use the supernatant for pH determination
Water soluble substances
Not more than 0.24%
See description under TESTS
Sulfated ash Not more than 0.05%
Proceed as directed under the test for Ash (Sulfated Ash, Method I) using 2 g of the sample
Lead Not more than 2 mg/kg
Prepare a sample solution as directed for organic compounds in the Limit Test and determine the lead content by atomic absorption spectrometry
Starch Not detectable
See description under TESTS
TESTS
PURITY TESTS
Water soluble substances
Shake 5 g of the sample with approximately 80 ml of water for 10 min, filter through Whatman No. 42 or equivalent filter paper into a tared beaker, evaporate to dryness on a steam bath and dry at 105掳 for 1h. Cool, weigh and calculate as percentage.
Starch Mix 30 g of the sample with 270 ml of water in a high-speed (18,000 rpm) blender for 5 min. Transfer 100 ml of the mixture to a 100-ml graduated cylinder, and allow to stand for 3h. A white opaque, bubble-free dispersion which does form a supernatant liquid at the surface, is obtained.

To 20 ml of this dispersion add a few drops of iodine TS, and mix. No purplish to blue or blue colour should be produced.

METHOD OF ASSAY Transfer about 125 mg of the sample, accurately weighed, to a 300-ml Erlenmeyer flask, using about 25 ml of water. Add 50.0 ml of 0.5N potassium dichromate, mix, then carefully add 100 ml of sulfuric acid, and heat to boiling. Remove from heat, allow to stand at room temperature for 15 min, cool in a water bath, and transfer into a 250-ml volumetric flask. Dilute with water almost to volume, cool to 25 掳, then dilute to volume with water, and mix. Titrate a 50.0-ml aliquot with 0.1N ferrous ammonium sulfate, using 2 or 3 drops of ortho-phenanthroline TS as the indicator, and record the volume required as S, in ml. Perform a blank determination, and record the volume of 0. IN ferrous ammonium sulfate required as B, in ml. Calculate the percentage of cellulose in the sample by the formula:

in which W is the weight of sample taken, in mg, corrected for Loss on Drying.