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- Alkaline Phosphatase (ALP) Reagent Alkaline Phosphatase (ALP) Reagent


Alkaline Phosphatase (ALP) Reagent
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General Information
1. Reagent Name: Alkaline Phosphatase (ALP) Reagent
2. Reagent Code: [Insert code]
3. Intended Use: The ALP reagent is intended for the quantitative determination of ALP activity in human serum or plasma.
4 x 25 ml (100T)
Reagent Composition
1. Buffer: AMP (2-Amino-2-methyl-1-propanol) buffer (pH 10.5 ± 0.1)
2. Substrate: p-Nitrophenyl phosphate (pNPP) (10 mmol/L)
3. Magnesium ions: Magnesium chloride (MgCl2) (1 mmol/L)
4. Colorimetric indicator: None required, as the reaction produces a yellow-colored product (p-nitrophenol)
Physical and Chemical Characteristics
1. Appearance: Clear, colorless solution
2. pH: 10.5 ± 0.1
3. Temperature: 20-25°C
4. Viscosity: 1.5-2.5 mPa·s
Performance Characteristics
1. Linearity: The reagent should exhibit a linear response to ALP activity over the range of 0-500 U/L.
2. Sensitivity: The reagent should be sensitive enough to detect ALP activity as low as 10 U/L.
3. Specificity: The reagent should be specific for ALP activity and not be affected by other enzymes or substances.
4. Precision: The reagent should exhibit good precision, with a coefficient of variation (CV) of less than 5%.
Stability and Storage
1. Stability: The reagent should be stable for at least 12 months from the date of manufacture when stored at 2-8°C.
2. Storage: Store the reagent at 2-8°C, away from direct sunlight.
Safety Precautions
1. Handling: Handle the reagent with care, as it may contain hazardous chemicals.
2. Disposal: Dispose of the reagent according to local regulations and guidelines.
Regulatory Compliance
1. CLSI: The reagent should meet the standards for ALP measurement as specified by CLSI (Clinical and Laboratory Standards Institute).
2. FDA: The reagent should comply with FDA regulations for in vitro diagnostic devices.
3. ISO: The reagent should meet the standards for quality and safety as specified by ISO (International Organization for Standardization).
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