On-Site EP/USP Blood Storage Container Testing

Project Description

URGENT
MULTIPLE TESTS

Pharmaceutical Laboratory needed for performing the following on-site EP/USP tests for blood storage containers as below:


Extract preparation Container
Ext prepn: fill bag with 450ml WFI, A/c at 110±2°C, 30mnts Materials for container Ext prepn: 25g with 500ml WFI, A/c at 121±2°C, 20mnts Material
Ext prepn: 25g with 500ml WFI, A/c at 121±2°C, 20mnts
Acidity < 0.4ml of 0.01N NaOH < 1.5 ml of 0.01N NaOH < 1.5 ml of 0.01N NaOH
alkalinity < 0.8 ml 0.01N HCl < 1 ml 0.01N HCl < 1 ml 0.01N HCl
UV < 0.1 in the range of 251 nm to 360nm.
< 0.3 in the range of 230 nm to 250nm. < 0.25 in the range of 250 nm to 310nm. < 0.25 in the range of 230 nm to 360nm.
Reducing substances < 2 ml/20 ml < 2 ml/20 ml -
Chlorides < 0.4µg/ml -
Residue on evaporation < 3 mg/100ml -
NH3 < 2 mg/L -
Heavy metals < 50ppm
Metals
(atomic absorption spectrometry) Ba<5ppm
Cd<0.6ppm
Ca<0.07%
Sn<20ppm
Zn<0.2%
Water extractable sub< 0.3%

P.aromatic amines <20ppm Ar,Cd,Pb,Co,Ni,V - < 0.01 mg/L
Ba<0.25 mg/L
Ca<0.07%
Sn<20ppm
Zn<0.2%


Raw material

PVC
VCM DEHP<40%(Gas cr+ mass sp)
DINCH < 45%
BTHC < 45%
TOTM< 45%
DEHT< 45%



IR

<1ppm (Gas cr)

DEHP<40%(Gas cr+ mass sp)
DINCH < 45%
BTHC < 45%
TOTM< 45%
DEHT< 45%


Cast+Zn st < 1%

ESBO < 6-8% (TLC)


IR

<1ppm(Gas cr)
Estimation TLC method
Residue weight
DEHP< 40mg
ESBO< 10mg
DSC Tg diff<8°C
TOC < 5 mg/L