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Key Documents

PHR1441

Supelco

Spectinomycin Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Spectinomycin sulfate tetrahydrate

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About This Item

Empirical Formula (Hill Notation):
C14H26N2O11S · 4H2O
CAS Number:
Molecular Weight:
502.49
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0000655
traceable to USP 1618003

API family

spectinomycin

CofA

current certificate can be downloaded

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

InChI

1S/C14H24N2O7.H2O4S.4H2O/c1-5-4-6(17)14(20)13(21-5)22-12-10(19)7(15-2)9(18)8(16-3)11(12)23-14;1-5(2,3)4;;;;/h5,7-13,15-16,18-20H,4H2,1-3H3;(H2,1,2,3,4);4*1H2/t5-,7-,8+,9+,10+,11-,12-,13+,14+;;;;;/m1...../s1

InChI key

OBZDRKHRQYPQDZ-SACNDDTHSA-N

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General description

Spectinomycin is an aminoglycoside-like antibiotic produced by Streptomyces spectabilis. It is widely used as a veterinary medication to treat gastrointestinal and respiratory infections caused by a variety of spectinomycin-sensitive micro-organisms.

Application

Spectinomycin Sulfate may be used as a pharmaceutical reference standard for the determination of the analyte in spectinomycin formulations using high-performance liquid chromatography technique.
Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis. It has been shown to have a wide variety of uses, including treating acute gonorrheal urethritis and cervictis, to mark cell layers to monitor cell fate during leaf development, as a selection marker in plant related transformation systems for plant cells containing the marker gene Spcr, to study respiratory tract infections of cattle caused by Pasteurella multocida and Mannheimia haemolytica, and to generate plants deficient for the plastid-encoded RNA polymerase on MS-agar media. Spectinomycin also has use in amplification of low copy number plasmid carrying replicons. It is recommended for use in cell culture applications at 7.5-20 mg/L.
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.

Caution

Solutions can be stored at 2-8°C for several weeks or at -20°C for more extended periods.

Preparation Note

Stock solutions should be prepared at 10 mg/mL in water and filter sterilized.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB3670 in the slot below. This is an example certificate only and may not be the lot that you receive.

Legal Information

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards. These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available. This product was designed, produced and verified for accuracy and stability in accordance with ISO/IEC 17025:2005 (AClass Cert AT-1467), ISO GUIDE 34:2009 (AClass Cert AR-1470).

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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A validated stability-indicating HPLC method for routine analysis of an injectable lincomycin and spectinomycin formulation
Abualhasan NM, et al.
Scientia Pharmaceutica, 80(4), 977-986 (2012)

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