Quality Control Criteria

QUALITY CONTROL CRITERIA

Quality Control Criteria for Ultra-Pure DNA Intermediates

Quality Policy Statement:- EssCee Biotech (I) Pvt. Ltd dedicated to producing high quality products tailored towards DNA/RNA synthesis to our customers through:

Excellence in Manufacturing
Long Term Relationships
Providing Value
Satisfaction
Strive for on time Delivery
Continually improving the effectiveness of our Quality Management System.

HPLC

Greater than 98% purity by HPLC.

UV - The UV test provides 4 values of data:

The ratio between 250/260 nm.
The ratio between 260/280 nm.
E-max position.
Extinction Coefficient.

MASS Spectrum

ESI-MS performed.

1H NMR

Proton NMR analysis is performed

LC/MS

LC/MS performed.
Moisture Content: < 0.10%

TLC

Single spot with no other visible impurity on spotting.

GC/MS

GC/MS analysis for solvents.

Metrohm Karl Fischer

Equipment used for Analytical function

GC/MS
HPLC
LC/MS
Metrohm Karl Fischer
Analytical Balance
GC with FID
UV visible spectrometer
Conductivity meter
pH meter
Spectra lab Karl Fischer
Melting point Apparatus & many others