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Spectradyne™ Product Information
The effective and mild antimicrobial.
Especially suited for use in preoperative scrubs, wound disinfection and wound protectants. Large body of literature existing to attest Chlorhexidine Gluconate's low toxicity.
Clinical studies have shown low irritancy and low allergic reactions in humans.
Spectradyne™ Product Information
The effective and mild antimicrobial.
Especially suited for use in preoperative scrubs, wound disinfection and wound protectants. Large body of literature existing to attest Chlorhexidine Gluconate's low toxicity.
Clinical studies have shown low irritancy and low allergic reactions in humans.
1. Active matter
1,1'-Hexamethylene bis(5- (4-chlorophenyl)biguanide)digluconate
1.1 CAS No.: 18472-51-0
1.2 EINECS No.: 242-354-0
1.3 UN No.: 3082
1.4 INCI-Name: Chlorhexidine Digluconate
2. Specifications
2.1 Apperance almost colourless or pale-yellowish clear liquid
2.2 Identification
2.2.1
2.2.2
2.2.3
2.2.4 Test A (IR) Test B (TLC)
Test C (Melting Point) Test D (Centrimide Test) Conforms to Standard Conforms to Standard 132.0 – 136.0
Conforms to Standard
2.3 Assay 190 – 210 g/l
2.4 4-Chloroaniline < 500 ppm
2.5 Relative density / 20°C 1.060 - 1.070
2.6 pH (5 % in water) 5.0 - 7.0
2.7 Related Substances
2.7.1 Impurity A BDL < 0.4 %
2.7.2 Impurity B ND < 0.2 %
2.7.3 Impurity F BDL < 0.2 %
2.7.4 Impurity G BDL < 0.3 %
2.7.5 Impurity H BDL < 0.5 %
2.7.6 Impurity I + O ND <0.4 %
2.7.7 Impurity J BDL < 0.4 %
2.7.8 Impurity K BDL < 0.4 %
2.7.9 Impurity L BDL < 0.2 %
2.7.10 Impurity N ND < 1.0 %
2.7.11 Impurity Q ND < 0.2 %
2.7.12 Any Unspecified Impurities ND < 0.10 %
2.7.13 Total impurities BDL < 3.0 %
2.8 Declaration Compliant with US Pharmacopoeia and European Pharmacopeia 7.8
BDL = Below, Disregard Limit (As per EP) ND = None Detected
3. Properties
3.1 Odour Mild
3.2 Water 80.0 % approx.
3.3 Ionogenicity Cationic
3.4 Solubility soluble in water and in polar solvents, such as lower alcohols, glycols and other polyols
4. Registrations
4.1 Europe European Inventory of Existing Chemical Substances (EINECS)
Listed as a preservative for cosmetics on the EEC positive list (0.3 %, reference no. 42)
4.2 USA Toxic Substances Control Act (TSCA) Inventory
4.3 Australia Australian Inventory of Chemical Substances (AICS)
4.4 Japan Approved by the MHW as a preservative for cosmetic uses.
5. Antimicrobial efficacy
5.1 BACTERIA
MIC values ppm Spectradyne
GRAM POSITIVE
Bacillus subtilis 1.4 – 3.0
Bacillus cereus 3.0
Bacillus megatherium 1.0
Clostridium welchii 70.0
Clostridium novyi 1.8
Clostridium tetani 7.0
Clostridium botulinum 3.5
Clostridium perfringens 14.0
Streptococcus pyogenes 0.6 5.0
Streptococcus faecalis 1.4 - 3.0
Streptococcus mutans 0.1
Streptococcus lactis 1.4
Streptococcus pneumoniae 7.0
Staphylococcus aureus 1.0 - 2.0
Staphylococcus albus 1.0
Staphylococcus epidermidis 5.0
Corynebacterium diphtheriae 5.0
Corynebacterium acne 10.0
Micrococcus luteus (Sarcina lutea) 2.0
Mycobacterium tuberculosis 0.7 - 6.0
GRAM-NEGATIVE
Escherichia coli 1.0 - 5.0
Salmonella dublin 2.5 - 15.0
Salmonella typhi 1.6
Salmonella typhosa 2.5
Salmonella pullorum 7.0
Salmonella typhimurium 14.0
Shigella flexneri 1.5
Shigella sonnei 1.6
Klebsiella aerogenes 1.5 - 12.5
Klebsiella pneumoniae 6.2
Enterobacter cloacae 2.5 - 3.2
Proteus mirabilis 25.0 - 100.0
Proteus morgani 25.0 - 43.0
Proteus vulgaris 7.0 - 25.0
Proteus rettgeri 3.0 - 100.0
Pseudomonas fluorescens 10.0
Pseudomonas aeruginosa 3.0 - 60.0
Aeromonas aerogenes 12.5
Vibrio cholerae 7.0
5.2 YEASTS
MIC values ppm Spectradyne
Candida albicans 7.0 - 15.0
Trichophyton mentagrophytes 2.5
Trychophyton tonsurans 14.0
Microsporum audouini 14.0
Microsporum gypseum 14.0
Microsporum canis 18.5
Saccharomyces ellipsoideus < 50
Saccharomyces cerevisiae < 50
Schizosaccharomyces octosporus 125
Schizosaccharomyces pombe < 50
5.3 MOULDS
MIC values ppm Spectradyne
Aspergillus versicolor 75
Aspergillus niger < 200
Rhizopus nigricans 175
Trichoderma viride 125
Mucor plubeus 125
Penicillium notatum 200
Penicillium roqueforti 150
Sporendonemma spp. < 50
5.4 VIRUS
Influenza A virus (H1N1)
Results according EN 14476: 2005
Clean conditions 4% test concentration 30 sec. contact time
Certificate: Microbial Control Laboratory, Lonza Inc., Allendale USA, September 2009.
6. Other investigations
Information available upon request.
7. Use areas
Preservative for cosmetics Hospital Application
- Preoperative scrubs - Wound disinfectants - Wound protectants
- Disinfecting ointments in obstetrics - Solution for bladder irrigation, catheter lubrication
- Sterile instrument storage OTC Applications
- Toothpaste - Gargle solutions - Throat sprays
- Lozenges for treating mouth and throat infections Veterinary Applications
- Teat Dip formulations
8. Recommendations to formulate
Incompatible with anionic surfactants.
9. Analytical procedure
TLC, IR
10. Packaging / Storage
Spectradyne™ is supplied in polyethylene drums holding 200 kgs net and IBC’s holding 1000 kgs net. Spectradyne™ and its formulated products should be packaged in opaque containers and stored away from heat. If Spectradyne freezes, thaw material at room temperature and mix thoroughly to insure uniformity of the solution. Spectradyne™ can be stored for at least 2 years in the sealed original packaging under normal temperature conditions.
11. Regulatory information
refer to MSDS
12. Toxicological information
refer to MSDS
13. Ecological and ecotoxicological information
refer to MSDS
