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Key Documents

PHR1597

Supelco

CMIT/MIT

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

5-chloro-2-methyl-2h-isothiazolin-3-one/2-methyl-2h-isothiazol-3-one

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About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

API family

cmit/mit

form

liquid

CofA

current certificate can be downloaded

packaging

ampule of 1 mL

application(s)

pharmaceutical (small molecule)

storage temp.

2-30°C

General description

Pharmaceutical secondary standard for applications in quality control, provides pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
CMIT/MIT is an isothiazolone biocide having a 3:1 ratio of CMIT and MIT, widely used for its broad-spectrum action against microbes, algae, and fungi. It is one of the active ingredients of humidifier disinfectants and a commonly used preservative in industrial products such as cosmetics, paints, adhesives and detergents.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H315,H317,H319,H412

Hazard Classifications

Aquatic Chronic 3 - Eye Irrit. 2 - Skin Irrit. 2 - Skin Sens. 1

Storage Class Code

12 - Non Combustible Liquids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAC6520
LRAB7781
LRAB0761
LRAA4713

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ProClin™ 300 pkg of 50 mL, ProClin™ preservative for use in IVD manufacturing, CMIT/MIT 3 %

Sigma-Aldrich

48912-U

ProClin™ 300

The mechanism of action of isothiazolone biocides
Williams TM
PowerPlant Chemistry, 9(1), 14-14 (2007)
Refined exposure assessment for three active ingredients of humidifier disinfectants
Lee JH, et al.
Environmental Engineering Research, 18(4), 253-257 (2013)
Fatal misuse of humidifier disinfectants in Korea: importance of screening risk assessment and implications for management of chemicals in consumer products
Lee JH, et al.
PowerPlant Chemistry, 9(1), 14-14 (2012)
Risk Assessment of 5-Chloro-2-Methylisothiazol-3 (2H)-One/2-Methylisothiazol-3 (2H)-One (CMIT/MIT) Used as a Preservative in Cosmetics
Kim MK, et al.
Toxicological Research, 35(2), 103-103 (2019)
CMIT/MIT induce apoptosis and inflammation in alveolar epithelial cells through p38/JNK/ERK1/2 signaling pathway
Lee J, et al.
Molecular & Cellular Toxicology, 15(1), 41-48 (2019)

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