Merck
All Photos(1)

PHR1064

Supelco

Residual Solvents Mixture - Class IIA

Pharmaceutical Secondary Standard; Certified Reference Material

NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

suitable for USP 467
traceable to USP 1601281

CofA

current certificate can be downloaded

application(s)

environmental
pharmaceutical (small molecule)

format

multi-component solution

storage temp.

2-30°C

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General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Residual Solvents Mixture - Class IIA are certified reference materials (CRMs) for the analysis of residual solvents. The residual solvents can be found as mixtures, as single-analyte standards, as well as neat CRMs. These CRMs are secondary pharmaceutical reference standards and are traceable and qualified against the corresponding Pharmacopeial standards.

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 (PhEur) 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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB7797 in the slot below. This is an example certificate only and may not be the lot that you receive.

Analyte

Description

    Acetonitrile 2 mg/mL
    Chlorobenzene 2 mg/mL
    Cumene 0.3 mg/mL
    Cyclohexane 14 mg/mL
    cis-1,2-Dichloroethene 4 mg/mL
    trans-1,2-Dichloroethene 4 mg/mL
    Methylene Chloride 3 mg/mL
    1,4-Dioxane 2 mg/mL
    Methanol 15 mg/mL
    Methylcyclohexane 5 mg/mL
    Tetrahydrofuran 4 mg/mL
    Toluene 4 mg/mL
    Ethylbenzene 2 mg/mL
    p-Xylene 1 mg/mL
    m-Xylene 1 mg/mL
    o-Xylene 7 mg/mL
    See All (16)

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Hazard Classifications

Aquatic Chronic 3 - Carc. 1B

Storage Class Code

6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 2

Flash Point(F)

188.6 °F - closed cup

Flash Point(C)

87 °C - closed cup


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

EU REACH SVHC Candidate List

CAS No.

EU REACH Annex XVII (Restriction List)

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Origin

Enter Lot Number to search for Certificate of Origin (COO).

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