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C-13 B. T. Substrates

These products are utilised in new class of non-invasive diagnostic tests used in clinical medicine. They have been developed with the intention of simplifying traditional tests of metabolic functions that often required intubations or collection and analysis of feces or urine.


Code

Substrate

Application

INC670P

Urea [13C, 99%]

Helicobacter pylori detection and eradication control

INC670P75

Urea [13C, 99%] tube of 75mg

Helicobacter pylori detection and eradication control

INC650P

Mixed Triglyceride [2-octanoyl(1-13C) - 1,3 distearoyl glycerol]

Pancreatic lipase activity evaluation

INC507P

Aminopyrine [N,N-dimethyl-13C2]

Liver function evaluation (Cyt. P-450 complex)

INC590P

Methacetin [N-(4-Methoxy-13C-phenyl)acetamide]

Liver function evaluation (Cyt. P-450)

INC610P

Octanoic acid [1-13C]

Gastric emptying

INC639P

Sodium acetate [ 1-13C]

Gastric emptying (liquid)

INK579P

Lactosyl - ureide (unlabeled)

Oro-caecal transit time measurement

INC582P

Lactosyl-ureide (13C Urea)

Oro-caecal transit time measurement

INC578P

2-Ketoisocaproic acid [1-13C]

Hepatic mitochondrial function

INC525P

Cholesteryl-3-octanoate [1-13C]

Pancreatic insufficiency evaluation



1. Principle

Carbon-13 Breath tests have the common characteristic that the labelled substrate is given orally. The chosen substrate bears a functional group in which a normally present 12C atom has been replaced by the stable isotope 13C (non radioactive). This functional group is cleaved enzymatically under specific circumstances, either during the absorption, the gastro-intestinal transit, or the metabolisation of the absorbed substrate.

The key metabolic function is followed by measuring the increase of 13CO2 in the subject's breath over a period of time.

2. Advantages

  • Carbon-13 Breath tests are a non-invasive method.
  • They enable us to measure gastro-intestinal, hepatological and metabolic functions directly in several physiological conditions.
  • Taking breath samples is a simple procedure
  • The use of 13C permits a short term repeat of breath tests on the same subject and the study of metabolic function in children and during pregnancy.

3. Labelled-substrates

The 13CO2 mixes with the body pool of CO2-HCO3 and is breathed out.
The exhalation of 13CO2 reflects the function we want to investigate.

4. Analysis

We are pleased to assist you by providing technical information on applications and literature references. All our 13C-substrates are controlled with modern analytical methods and delivered with a complete Certificate of Analysis :
  • To determine the Chemical purity (99 %) we make HPLC, 13C-NMR, 1H-NMR, Infra-red spectrum analysis
  • To determine the Isotopic Enrichment (99 atom %), we make Mass spectrometry analysis
  • To determine the Pyrogenicity, we make Limulus test
  • For 13C-Urea we make also all the analysis recommended by the European Pharmacopoeia

Certificate of analysis - UREA 13C

EURISO-TOP monography

ANALYSIS RESULTS SPECIFICATIONS
Chemical purity :

- NMR 1 H
- NMR 13 C 		>= 99 %
>= 99 % 		>= 99 %
>= 99 %
Identification :

- FT-IR spectrometry - Sample vs Standard
isotopic enrichment :

- Mass spectrometry >= 99 Atom % 13 C >= 99 Atom % 13 C
Water content :

- Karl Fisher Titration 0.11% < 1 %
Pyrogenicity :

- L.A.L. Test < 0.125 EU/mg < 0.125 EU/mg
Ammonium content

- NFT 90.015 NORM < 30 ppm < 500 ppm

European Pharmacopoeia (3rd edition - 1997)


ANALYSIS RESULTS SPECIFICATIONS
Characteristics : White cristalline powder, slightly hygroscopic White crystalline powder, slightly hygroscopic
Solubility :

- Water
- Alcohol
- Methylene chloride 		Very soluble
Soluble
Insoluble 		Very soluble
Soluble
Insoluble
Identification :

- A) Melting point
- C) Chemical reaction (HNO 3 )
- D) Coloured reaction (NaOH) 		134°C
Conforms
Conforms
 132C-135C
White precipitate
Reddish-violet colouration
Assays :

- Solution appearance
- Alcalinity
- Biuret
- Ammonium
- Heavy metals
- Loss on drying
- Sulfated ashes 		Conforms
Conforms
< 0.1 %
< 500 ppm
< 10 ppm
< 1 %
< 0.1 % 		Clear, colourless solution
Red-orange solution
0.1 %
500 ppm
10 ppm
1 %
0.1 %
Titration : 100.1 % Urea 13 C contains not less than 99 % and not more than 101 % of 13CH 4 N 2 O

Residual solvents


ANALYSIS RESULTS SPECIFICATIONS
- Ethyl alcohol
- Methyl alcohol
- Ethyl ether 		< 23 ppm
< 10 ppm
49 ppm 		500 ppm
200 ppm
200 ppm
Analyst signature Decision Pharmacist signature

Date : December 2007
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