Pharmaceutical Refractometer
Industry Description For Pharmaceutical Refractometer
Pharmaceutical measurement demands meeting the required standard, for example USP<831>, EP2.2.6 and similar. There is no “good enough” in pharma, additives and formulations must meet USP requirements. Documentation is also key, simply generating a number is not enough. The laboratory has to be able to prove calibration and, when it is operating under 21 CFR 11; document who did the measurement and create an audit trail showing every interaction with the pharmaceutical refractometer. Additionally, the operating software and data security has to be proven to work by an IQOQPQ before acceptance. From a measurement system point of view it is also important that the instrument has the broad range to measure pharmaceuticals. This includes materials like sevoflurane (RI of 1.26) and cinnamon oil (RI of 1.61). A food or even a general chemical refractometer usually does not have sufficient range to cover this.
Reasons to Choose Rudolph
- Proven 21 CFR 11 system with electronic signature and full audit trail documentation.
- Detailed IQOQPQ using traceable standards across the whole range of the instrument.
- Wide enough range to measure everything in the USP / EP / BP / IP / CP / JP.
Typical Rudolph Users
- Reference laboratories like the USP need to be able to measure EVERY material in the Pharmacopeia and find the wide range of the J257 essential.
- GSK, Merck, Pfizer all use the J series for checking incoming raw materials.
- Biogen uses the J series for in process concentration measurement.
Refractometer Selections by Industry
J457 an ideal Pharmaceutical Refractometer or Hospital Toxicology Refractometer.
A high accuracy Pharmaceutical refractometer for research, hospital refractometer toxicology testing, compounding, and drug monitoring may require instruments with reliable temperature control, compliance tracking, and specific measurement ranges. Does your application require you to measure…
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A pharmaceutical refractometer requires specific features
Enflurane, Sevoflurane and similar halogenated ethers are used extensively for the induction and maintenance of general anesthesia. Their manufacture must comply with specifications from the USP/EP or relevant pharmacopeias. Many of these pharmacopeias require the measurement of refractive index. For example, the US Pharmacopeia requires that sevoflurane has a refractive index of 1.2745 – 1.2760 at 20°C. For 21 CFR Part 11 compliance choose the 21 CFR Part 11 option.
| Refractometer Model | Specification | Features and Benefits |
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Measurement Range: 1.26 – 1.70 RI; 0 – 95% Brix Accuracy:0.0001 RI; 0.1 Brix Electronic Temperature Control:Flexible temperature selection between 15°C – 70°C |
USP General Subchapter <831> Refractive Index States: …Although the standard temperature for Pharmacopeial measurements is 25°C, many of the refractive index specifications in the individual monographs call for determining this value at 20°C. The temperature should be carefully adjusted and maintained, since the refractive index varies with the temperature… …To achieve the theoretical accuracy of ±0.0001, it is necessary to calibrate the instrument against a standard provided by the manufacturer and to check frequently the temperature control and cleanliness of the instrument by determining the refractive index of distilled water, which is 1.3330 at 20°C and 1.3325 at 25°C… The J357 refractometer provides the refractive index range, accuracy, performance and optional 21 CFR Part 11 compliance demanded by large pharmaceutical firms making this a popular pharmaceutical refractometer. |
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Measurement Range: 1.26 – 1.70 RI; 0 – 95% Brix Accuracy:0.00004 RI; 0.03 Brix Electronic Temperature Control:Flexible temperature selection between 15°C – 100°C; TB option: allows 15°C – 110°C with one hour boost to 120°C |
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| Medical Testing and Toxicology Models | Specification | Features and Benefits |
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Measurement Range: 1.33 – 1.53 RI; 0 – 95% Brix, 1.000 – 1.0500 Urine SG Accuracy:0.0002 Urine SG; 0.00004 RI; 0.01 Brix Electronic Temperature Control:Fixed temperature selection: 20°C and 25°C |
The J-Series Refractometer is chosen by more toxicology labs than any other brand. These customers know that 0.0002 Urine SG accuracy must be validated regularly and Rudolph’s J57 pharmaceutical refractometer ensures that the refractive index performance and calibration requirements meet government regulations. The J57HA’s standard sample volume is 500 micro liters but this can be reduced to 100 micro liters by selecting theJ57HA-SV. |
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Measurement Range: 1.33 – 1.53 RI; 0 – 95% Brix, 1.000 – 1.0500 Urine SG Accuracy:0.0002 Urine SG; 0.00004 RI; 0.01 Brix Electronic Temperature Control:Fixed temperature selection: 20°C and 25°C |
SAMSHA labs doing hundreds of toxicology samples per day prefer to eliminate the human factor and choose large scale automation. The J57HA-UF-SP refractometer is combined with a custom automation solution that minimizes sample use and replaces the tested sample to the testing vial. |
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Measurement Range: 1.33 – 1.53 RI; 0 – 95% Brix, 1.000 – 1.0500 Urine SG Accuracy:0.0002 Urine SG; 0.00004 RI; 0.01 Brix Electronic Temperature Control:Fixed temperature selection: 20°C and 25°C |
For large hospitals doing their own pharmaceutical compounding, ensuring that their Total Parenteral Nutrition formulas are accurate is life critical. The J57TPN is a Hospital Specific pharmaceutical refractometer and was specifically customized to meet USP<797>. Please contact the factory for the white paper on this application. |
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Measurement Range: 1.26 – 1.72 RI; 0 – 100% Brix Accuracy: 0.00002 RI; 0.015 Brix Electronic Temperature Control: Flexible temperature selection between 10°C to 100°C with ±0.01°C reproducibility. |
Rudolph’s most capable Pharmaceutical Refractometer. Perfect for today’s highly regulated laboratories offering full 21CFR Part 11 compliance. Rudolph Research is the first manufacturer to offer Smart Measure™ a system that notifies the operator of the quality and status of the sample load, as well as the sample well status. This assists the operator in producing more accurate readings, and actually documenting that the sample was properly loaded. The J457 is available in 3 configurations J457 SC – Standard Bench-top, J457 WC – Wall Mount, and the J457 FC – Factory Configuration. These configurations allow the measurement unit to be isolated from the display unit, thus protecting it from harsh environments and messy spills. |
