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BRD TEAM
Elemental Analysis :ICP OES
(Inductively Coupled Plasma Optical Emission Spectrometry)
Increasingly, ICP-MS and ICP-OES methods of analysis are being used to quantify the concentration of elements contained in pharmaceutical compounds. Validation of methods for quantification of elements in biological matrices such as whole blood, serum, plasma, cerebrospinal fluid, urine, milk, bone, homogenized organs and tissues may be performed following GLP predicate rules and bio analytical guidance. Veeda has experience in carrying out studies for different elements in different types of biological matrices
Few Examples
- Platinum (Pt) is a component of cisplatin, carboplatin and oxiplatin: all used for oncology treatments
- Iron (Fe) from Iron Sucrose, Ferumoxytol, Ferric Carboxymaltose, Sodium Ferric Gluconate and Iron Dextran
- Lithium (Li) Carbonate indicated in the treatment of manic episodes of manic-depressive illness.
- Potassium (K) chloride For the treatment of patients with hypokalemia.
- Magnesium (Mg) glycerophosphate is given to supplement magnesium levels when the level of magnesium in the body is too low for the patients with chronic magnesium loss or hypomagnesaemia
WHY VEEDA?
Veeda has hands on experience of conducting studies on elements like Lithium , Potassium, Magnesium and iron Sucrose with a very good ISR pass percentage . The team has now experience in handling various molecules and the results generated are as per the CFR compliant which is done by adding strong IT controls for the data integrity part .the results are generated through Watson LIMS and then exported to Stats for further processing
| Analyte Name | No. of Study Perform | Matrix Used | ISR Percentage |
|---|---|---|---|
| Lithium (Li) | 3 | Human Plasma | 98.50% |
| Potassium (K) | 10 | Human Urine | 96.40% |
| Magnesium (Mg) | 1 | Human Serum | 92.68% |
| Iron (Fe) for Iron Sucrose | 4 | Human Serum | 91.73% |
| Iron (Fe) Sodium Ferric Gluconate | 1 | Dog Serum | 99.20% |
| Iron (Fe) Ferric Carboxymaltose | 1 | Dog Serum | 88.72% |
| Iron (Fe) Iron Dextran | 1 | Dog Serum | 74.80% |
Our exemplary regulatory track record
USFDA
33 times
Brazil ANVISA
7 times
WHO
5 times
UK MHRA
3 times
EU - AGES
1 times
South Africa - MCC
1 times
NPRA - Malaysia
4 times
DCGI
13 times