CTP, GMP Grade, AOF

英文名:CTP, GMP Grade, AOF

货号:09745122103

规格:100 mL

报价:价格面议

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商品描述

 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.
In contrast to the standard concentration of 100 mM, the higher concentrated 325 mM soltution, allows you a higher degree of freedom in the setup of you IVT-conditions.
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]): 310-340 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.
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