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PHR1077

Gentamicin Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyma:

Gentamicin sulfate salt

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Vám/Skladová položkaDostupnostCena
1 g
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3 420,00 Kč

O této položce

Číslo CAS:
PubChem Substance ID:
UNSPSC Code:
41116107
NACRES:
NA.24
EC Number:
215-778-9

3 420,00 Kč


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Quality Segment

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. G0200000, traceable to USP 1289003

API family

gentamicin

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

SMILES string

O=S(O)(O)=O.O[C@]1(C)[C@@H]([C@@H](O)[C@@H](O[C@@H]2[C@@H](O)[C@H](O[C@H]3O[C@@](CC[C@H]3N)([C@@H](C)NC)[H])[C@@H](N)C[C@H]2N)OC1)NC.O[C@]4(C)[C@@H]([C@@H](O)[C@@H](O[C@@H]5[C@@H](O)[C@H](O[C@H]6O[C@@](CC[C@H]6N)([C@@H](C)N)[H])[C@@H](N)C[C@H]5N)OC4)NC.O[

InChI

1S/C21H43N5O7.C20H41N5O7.C19H39N5O7.H2O4S/c1-9(25-3)13-6-5-10(22)19(31-13)32-16-11(23)7-12(24)17(14(16)27)33-20-15(28)18(26-4)21(2,29)8-30-20;1-8(21)12-5-4-9(22)18(30-12)31-15-10(23)6-11(24)16(13(15)26)32-19-14(27)17(25-3)20(2,28)7-29-19;1-19(27)7-28-18(13(26)16(19)24-2)31-15-11(23)5-10(22)14(12(15)25)30-17-9(21)4-3-8(6-20)29-17;1-5(2,3)4/h9-20,25-29H,5-8,22-24H2,1-4H3;8-19,25-28H,4-7,21-24H2,1-3H3;8-18,24-27H,3-7,20-23H2,1-2H3;(H2,1,2,3,4)/t9-,10-,11+,12-,13+,14+,15-,16-,17+,18-,19-,20-,21+;8-,9-,10+,11-,12+,13+,14-,15-,16+,17-,18-,19-,20+;8-,9+,10-,11+,12-,13+,14+,15-,16+,17+,18+,19-;/m110./s1

InChI key

RDEIXVOBVLKYNT-HDZPSJEVSA-N

General description

Gentamicin is an aminoglycoside complex produced by fermentation of Micromonospora purpurea or M. echinospora. It is used as the sulfate salt. There are three components, each consisting of five basic nitrogens and requiresing five equivalents of sulfuric acid per mole of gentamicin base.


This broad-spectrum antibiotic, is widely used as an active pharmaceutical ingredient (API) with therapeutic potential against both Gram-positive and Gram-negative bacteria.[1]Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.

Application

Gentamicin Sulfate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations[1] using different chromatography techniques. It is also used as a selection agent (gentamicin-resistance gene) in cell culture and molecular biology applications. This product is recommended for use at 50 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.

Biochem/physiol Actions

Mode of action: Gentamicin causes codon misreading by binding to the 30S ribosomal subunit, blocking the translocation of peptidyl-tRNA from the acceptor site to the donor site. The bactericidal effect of gentamicin on Pseudomonas aeruginosa is exerted by the binding of gentamicin to the outer membrane, where it displaces natural cations, destabilizes the membrane, and forms holes in the cell surface.

Antimicrobial spectrum: Includes Gram-negative and Gram-positive bacteria, including strains resistant to tetracycline, chloramphenicol, kanamycin and colistin, particularly strains of Pseudomonas, Proteus, Staphylococcus and Streptococcus.

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.
To see an example of a Certificate of Analysis for this material enter LRAB3514 in the slot below. This is an example certificate only and may not be the lot that you receive.

Disclaimer

Sterile solutions should be stored at 2-8°C. Solutions have also been shown to be stable at room temperature and in boiling aqueous buffers of pH 2-142.

Porovnat podobné položky

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1 of 1

Tato položka
1289003G0200000BP174
Gentamicin sulfate European Pharmacopoeia (EP) Reference Standard

G0200000

Gentamicin sulfate

Gentamicin sulfate British Pharmacopoeia (BP) Reference Standard

BP174

Gentamicin sulfate

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

format

neat

format

neat

format

neat

format

neat

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

-

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

storage temp.

-10 to -25°C

storage temp.

-

storage temp.

-

storage temp.

2-8°C

CofA

current certificate can be downloaded

CofA

-

CofA

-

CofA

-


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pictograms

Exclamation mark

signalword

Warning

hcodes

Hazard Classifications

Skin Sens. 1

Skladovací třída

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable



Osvědčení o analýze (COA)

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Questions

1–5 of 5 Questions  
  1. How much is the potency of this product? For making a stock solution of gentamicine sulfate for antibiogram I need it.

    1 answer
    1. Potency for this product is batch-specific and appears on the Certificate of Analysis. Retrieve the CoA for the applicable lot to verify the potency, units (e.g., µg/mg or IU/mg), and the assay basis (e.g., dried basis or as-is). Use the CoA value and basis to prepare the stock solution with the appropriate conversion. Please see the link below to access a Certificate of lot interest:
      https://www.sigmaaldrich.com//product/sial/phr1077#product-documentation

      Helpful?

  2. Is the composition of gentamicin components C1, C1a, ..., knwon? At least an approximation would be nice.

    1 answer
    1. Yes, each form is identified and quantified by HPLC. These values are reported in the lot specific Certificate of Analysis. An example of each is provided below:
      Gentamicin C1a: 23.9 %
      Gentamicin C2: 33.7 %
      Gentamicin C2b: 0.40 %
      Gentamicin C2a: 13.25 %
      Gentamicin C1: 28.8 %
      Please see the link below to review a lot specific Certificate:
      https://www.sigmaaldrich.com/product/sial/phr1077#product-documentation

      Helpful?

  3. How can I determine the shelf life / expiration / retest date of this product?

    1 answer
    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/418/501/product-dating-information-06-25-mk.pdf

      Helpful?

  4. Hi, I would like to make a stock solution for antimicrobial susceptibility test. I would like to ask what is the molecular weight of this compound and how many grams of powder should I used to make a 10 mg/mL gentamicin solution? Thank you.

    1 answer
    1. Since there is an uncertain -R group in this product that contains three possibilities, the molecular weight can't be determined. To make a 10 mg/mL solution, the molecular weight is not needed. Simply weigh out the appropriate amount of the compound (e.g. 100 mg) and add it to the corresponding volume of solvent (e.g. 10 mL) to achieve a 10 mg/mL concentration. Please note this product is recommended for use at 50 mg/L.

      Helpful?

  5. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer
    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

      Helpful?

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