SPECTRADYNE-G

Spectradyne-G 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.: 2423540
1.3 UN No.: not applicable
1.4 INCI-Name: Chlorhexidine Digluconate

2. Specifications
2.1 Description almost colourless or pale-yellowish clear liquid,
2.2 Identification
 
2.2.1  a) Test B    TLC
2.2.2  b) Test C    Mp of CHD
2.2.3  c) Test D     Cetrimide Test
 
2.2.2 b) TCL TCL chromatogram conforms
2.3 pH 5.5 - 7.0
2.4 Relative density at 20°C 1.06 - 1.07
2.5 4-Chloroaniline < 500 ppm
2.6 Related substances (HPLC) < 3 %
2.7 Assay 19.0 - 21.0 % w/v of C22H30Cl2N10.2C6H12O7
2.8 Declaration PH EUR 3.97

3. Properties
3.1 Appearance clear, water white to amber liquid
3.2 Odour mild
3.3 Density (20°C) 1.06 - 1.07 g/cm3
3.4 Water 80.0 % approx.
3.5 Ionogenicity cationic
3.6 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-G

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-G
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-G
Aspergillus versicolor 75
Aspergillus niger < 200
Rhizopus nigricans 175
Trichoderma viride 125
Mucor plubeus 125
Penicillium notatum 200
Penicillium roqueforti 150
Sporendonemma spp. < 50

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
Product is supplied in polyethylene drums holding 200 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.

11.Regulatory information
refer to MSDS

12.Toxicological information
refer to MSDS

13.Ecological and ecotoxicological information
refer to MSDS