CTP, GMP Grade, AOF

NTPs are the critical starting materials of in vitro mRNA synthesis for therapeutics or vaccines.

CTP is produced using a sustainable, non-chemical process. In contrast to a chemical synthesis, this process avoids heavy metal catalysed processes. The production is completely animal origin free. To comply with regulatory requirements, it produced under GMP The manufacturing process is validated including the final filling step, followed by QC-release testing. The pH is adjusted to match conditions for in vitro transcription. To ensures you a stable pH during shipment on dry ice and constant product quality, the solution is supplied in sealed and CO2-proof bottles.

Fit for purpose GMP Grade quality

Animal-Origin-Free process (AOF)

Antibiotics-free process

Extended testing for impurities

Testing of Heavy Metals as contaminant

Regulatory document support

Application

Together with GTP, ATP, UTP and/or modified UTP, CTP is part of the ribonucleotide mix needed to synthesize mRNA in the presence of a RNA polymerase.

Properties

Nomenclature: Cytidine-5'-triphosphate

CAS Number: 65-47-4 (free acid)

Formula: C9H16N3O14P3 (free acid)

Molecular weight: 483.2 D (free acid)

Specifications

Appearance: Clear, colorless solution

pH value: 8.1-8.5 (25 °C ± 1 °C)

CTP (A260; pH 7.0 ε = 15.0 [L x mmol-1 x cm-1]): 100-110 mmol/L

CTP (HPLC): ≥ 98.5 area%

CDP (HPLC): ≤ 1.5 area%

CMP (HPLC): ≤ 0.5 area%

Sum from CTP + CDP + CMP (HPLC): ≥ 99.5 area%

Heavy metals (sum from V, Ni with ICP-MS): ≤ 10 ppm

Proteases (recovery Aldolase ≥ 80%): Corresponds to specification

Bioburden (TAMC): ≤ 5 CFU/ml

Endotoxins: ≤ 2 EU/ml

DNases/RNases: Negative

Nicking activity: Negative

Functional transcription assay: Corresponds to specification

Identity HPLC-MS: Corresponds to specification

Stability: At -15 to -25°C within specification range for 18 months from date of manufacture.

Regulatory Disclaimer

For further processing into medical devices, IVD and pharmaceutical products only.

 

License Disclaimer / Warranty Limitation

Warranty Limitation

 

It is the sole responsibility of the customer to determine the suitability of all raw materials, products and components in order to ensure that the final end-use product is safe for its end use; performs or functions as intended; and complies with all applicable legal and regulatory requirements. Roche makes no representations or warranties of any kind regarding the Product, express or implied, other than those expressly set forth in the terms and conditions of sale (if any), and disclaims all implied or statutory warranties including warranty of merchantability and fitness for a particular purpose.