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Povidone Iodine

TYPICAL CERTIFICATE OF ANALYSIS

TEST SPECIFICATION RESULT
Discription Reddish Brown Colour Powder
Reddish Brown Colour Powder
Solubility
Soluble in water & alcohol it is practically insoluble in acetone
Complies
Identification (A & B)
A : A deep blue colour produced
B : A dry brown colour film formed, which is readily dessolved in water
Complies

Complies
Heavy Metals
Maximum 20 ppm
< 20 ppm
Nitrogen
9.5% to 11.5% w/w
(on dried basis)
10.40% w/w
(on dried basis)
Iodide
Maximum 6.6% w/w
3.78% w/w
Complies
Sulphated Ash
Negligible
Complies
Loss on drying
Maximum 8.0% w/w
3.05% w/w
Assay 9.0% to 12.0% w/w
(on dried basis)
11.35% w/w of available Iodine
(on dried basis)

Povidone-PVP K-30

PVP K-30 USP/BP/ EP

Property Specifications Analysis
1. Appearance at  25 C   White to creamy white powder Passes
2. Reaction  with Potassium dichromate Positive Passes
3.Reactionwith Cobaltnitrate and Ammonium thiocyanate   Positive Passes
4. Reaction with iodine  Positive Passes
5. Moisture 5% max 0.16%
6. pH  3.0-7.0 3.21
7. Residue on ignition  0.1% max. 0.04%
8. Vinyl pyrrolidone 10 ppm max. 1.31 ppm
9.  K-value 27-34 33.02
10. Hydrazine < 1 ppm  <1 ppm
11. Nitrogen 11.5% - 12.8% 11.88%
12. Heavy metals  10 ppm max.  <10 ppm
13. Aldehydes  
( Calculated as Acetaldehyde )
500 ppm max. 330 ppm

Chlorhexidine

TYPICAL CERTIFICATE OF ANALYSIS

TEST SPECIFICATION RESULT
APPEARANCE WHITE  POWDER WHITE  POWDER
IR SPECTRUM TO MATCH REFERENCE STANDARD COMPLIES
MELTING POINT 132-136 CELCIUS 132-134 CELCIUS
RESIDUE ON IGNITION NOT MORE THAN 0.1 % W/W  0.05 % W/W
CHLOROANILINE (PCA) NOT MORE THAN 60 PPM COMPLIES
LOSS ON DRYING NOT MORE THAN 0.5 % W/W 0.2%
ASSAY

  BY HPLC :    NOT LESS THAN 98 % AND NOT 
MORE THAN 102 %

BY TITRATION : NOT LESS THAN 98 % AND NOT MORE THAN 102 %

  BY HPLC :    99.5 %

BY TITRATION : 99.8 %

COLOUR TEST ABSORBANCE NOT MORE THAN 0.03 AT 480 NM .008

CHLORHEXIDINE DIGLUCONATE   IP/BP/EP

CHLORHEXIDINE DIGLUCONATE 20 % w/v
Typical Certificate of Analysis

TEST SPECIFICATION RESULT
CHARACTERS AN ALMOST COLOURLESS OR PALE –YELLOWISH LIQUID , MISCIBLE WITH WATER , SOLUBLE IN ACETONE AND IN ALCOHOL AN ALMOST COLOURLESS LIQUID , MISCIBLE WITH WATER ,SOLUBLE IN ACETONE AND IN ALCOHOL
IDENTIFICATION

FIRST IDENTIFICATION        : A,B

SECOND IDENTIFICATION   : B,C,D.

 

COMPLIES
RELATIVE DENSITY 1.06-1.07 1.067
PH DILUTE 5.0 ML TO 100.0ML WITH CARDON DIOXIDE FREE WATER R . THE PH OF THE SOLUTION IS 5.5 TO 7.0 5.73
CHLOROANILINE (PCA) TO COMPLY WITH  BP TEST COMPLIES
RELATED SUBSTANCES

TO COMPLY WITH B.P TEST

TOTAL IMPURITY SHOULD BE LESS THAN 3 %

 

COMPLIES
ASSAY

CHLORHEXIDINE DIGLUCONATE SOLUTION IS AN AQUEOUS SOLUTION WHICH CONTAINS NOT LESS THAN 190 G/L AND NOT MORE THAN 210 G/L OF 1,1' HEXAMETHYLENENEBIS   [5-(4-CHLOROPHENYL)-BIGUANIDE]di(D-DIGLUCONATE ).

199.0 G/L
 

               MATERIAL SAFETY DATA SHEET

CHLORHEXIDINE DIGLUGONATE SOLUTION 20 %

SECTION I

Chemical Name: Chlorhexidine Gluconate Solution

SECTION II - HAZARDOUS INGREDIENTS

Ingredients CAS # % TLV PEL UNITS
Chlorhexidine Gluconate Solution 018472-51-0 100      

SECTION III - PHYSICAL DATA

Boiling Point (°F)

N/A

Specific Gravity (H2O=1)

N/A

Vapor Pressure (MM Hg)

N/A

Percent Volatile by Vol.

N/A

Vapor Density (Air=1)

N/A

pH

N/A

Solubility in Water

miscible

Evap Rate (Ether = 1)

N/A

Appearance and Odor

almost colorless to pale yellow

Form

liquid

SECTION IV - HAZARDOUS REACTIVITY

Instability - Stable.

Incompatibility - Solutions containing inorganic anions such as saline.

Decomposition - N/A

Polymerization - Polymerization will not occur.

SECTION V - FIRE AND EXPLOSION HAZARD DATA

Flash Point - N/A

Flammable Limits

LEL - N/A

UEL - N/A

Fire and Explosion Hazards - Presence of solid oxidizers.

Extinguishing Media - Water spray, foam, Carbon Dioxide and dry chemical.

Special Fire Fighting Procedures - Use supplied air respirators.

SECTION VI - HEALTH HAZARD INFORMATION 

Eye - Corrosive to eyes.

Skin - Primary skin irritant, could cause allergic reaction in some people.

Inhalation - Nasal discomfort, high concentrations may cause headaches.

First Aid

Eyes: Immediately flush eyes with large amounts of water for at least 15 minutes while holding the eyelids open. Get prompt medical attention.

Skin: Immediately remove contaminated clothing; wash skin with large amounts of water for at least 15 minutes. Get prompt medical attention.

Inhalation: Unlikely route of exposure,

Ingestion: Give two glasses of water. Do induce vomiting. Contact local Poison Control Center or physician immediately! 

SECTION VII - SPILL or LEAK PROCEDURES

Procedures - Contain spill with non reactive absorbent such as vermiculite.

Waste Disposal Method - Dispose of in accordance with Local, State, and Federal Regulations. 

SECTION VIII - SPECIAL PROTECTION INFORMATION

Respiratory - N/A.

Eyewear - Safety Glasses.

Clothing/Gloves - Plastic rubber.

Ventilation - Local exhaust may be necessary under some handling/use conditions. Specific needs should be addressed by supervisory or health safety personnel. 

SECTION IX - TRANSPORTATION INFORMATION

Shipping Information:

DOT-Domestic Ground Transportation

Proper Shipping Name Non-Hazardous Material 


MATERIAL SAFETY DATA SHEET

CHLORHEXIDINE BASE

SECTION I

Chemical Name: Chlorhexidine Gluconate Solution

SECTION II - HAZARDOUS INGREDIENTS

Ingredients CAS # % TLV PEL UNITS
Chlorhexidine Gluconate Solution 55-56-1 100      

SECTION III - PHYSICAL DATA

Boiling Point (°F)

N/A

Specific Gravity (H2O=1)

N/A

Vapor Pressure (MM Hg)

N/A

Percent Volatile by Vol.

N/A

Vapor Density (Air=1)

N/A

pH

N/A

Solubility in Water

miscible

Evap Rate (Ether = 1)

N/A

Appearance and Odor

white

Form

powder

SECTION IV - HAZARDOUS REACTIVITY

Instability - Stable.

Incompatibility - Solutions containing inorganic anions such as saline.

Decomposition - N/A

Polymerization - Polymerization will not occur.

SECTION V - FIRE AND EXPLOSION HAZARD DATA

Flash Point - N/A

Flammable Limits

LEL - N/A

UEL - N/A

Fire and Explosion Hazards - Presence of solid oxidizers.

Extinguishing Media - Water spray, foam, Carbon Dioxide and dry chemical.

Special Fire Fighting Procedures - Use supplied air respirators.

SECTION VI - HEALTH HAZARD INFORMATION 

Eye - Corrosive to eyes.

Skin - Primary skin irritant, could cause allergic reaction in some people.

Inhalation - Nasal discomfort, high concentrations may cause headaches.

First Aid

Eyes: Immediately flush eyes with large amounts of water for at least 15 minutes while holding the eyelids open. Get prompt medical attention.

Skin: Immediately remove contaminated clothing; wash skin with large amounts of water for at least 15 minutes. Get prompt medical attention.

Inhalation: Unlikely route of exposure,

Ingestion: Give two glasses of water. Do induce vomiting. Contact local Poison Control Center or physician immediately! 

SECTION VII - SPILL or LEAK PROCEDURES

Procedures - Contain spill with non reactive absorbent such as vermiculite.

Waste Disposal Method - Dispose of in accordance with Local, State, and Federal Regulations. 

SECTION VIII - SPECIAL PROTECTION INFORMATION

Respiratory - N/A.

Eyewear - Safety Glasses.

Clothing/Gloves - Plastic rubber.

Ventilation - Local exhaust may be necessary under some handling/use conditions. Specific needs should be addressed by supervisory or health safety personnel. 

SECTION IX - TRANSPORTATION INFORMATION

Shipping Information:

DOT-Domestic Ground Transportation

Proper Shipping Name Non-Hazardous Material