More information about ICP-MS
- What is elemental analysis by ICP-MS and do you perform it?
- Elemental analysis is an analytical technique that can determine trace to large concentrations of elements in raw materials, finished products, excipients, API, water, etc.Yes, we perform Elemental Analysis by ICP-MS for the following elements:
- When is elemental analysis by ICP-MS typically used?
- Effective as of January 1, 2018, the United States Pharmacopeia (USP) deleted Heavy Metals <231> methodology. Elemental analysis by ICP-MS is the preferred alternative. Products that typically require ICP-MS testing include transdermal ointments, inhalers, injectibles, capsule powders, etc.For the safety of all consumers, manufacturers are recommended to test all raw materials and supplements for their intended use.
- How are samples prepared?
- Sample preparation depends on the sample. While some water-soluble samples do not require digestion, most samples must be digested in a minimal acid solution that preserves the sample’s volatile elements. Depending on the sample, New Jersey Laboratories uses one of two types of microwave digestion systems. Microwave digestion is a technique that dissolves metals in the presence of organic molecules (i.e. carbon). This process typically requires high pressures and high temperatures in acidic conditions.
- How should samples be submitted for elemental analysis by ICP-MS?
- The best way to submit samples is in two separate sterile containers – one for method development and one for validation. The sample size would depend on the specifications and requirements.
- What information must be submitted along with the samples for elemental analysis by ICP-MS?
- Along with the product, clients must provide specifications, also known as target limits. The target limit is the pass-fail level at a 100%.A protocol must be written before samples can be submitted, and in order to write a protocol, a project’s elements, specifications, and any other special instructions must be submitted via email or attachments.Since elemental analysis by ICP-MS is not a routine analytical test, but rather, a customized process, please reach out to us to discuss your project’s needs before submitting any information.
- What types of products typically require ICP-MS testing?
- Excipients, API, finished products in powder, capsules, tablets, liquid forms, empty capsules, etc.
- What is validation, and why do samples need to be validated?
- During method development, different samples may behave differently under digestion, and as a result, digestion matrices and parameters may change from sample to sample. The validation process allows us to take these differences into account during analysis. Method development and validation also determine which gas modes and isotopes reduce interferences, which also allow for greater accuracy and precision of results.
- What samples need to be validated?
- Because the USP has not established specific methods, all samples should be validated. When validation is not performed, accuracy and precision are not guaranteed, and results are considered NON-GMP analysis.
- Why are no specific methods established in the USP?
- Since extensive method validation is required by multiple laboratories, the current USP does not specify analytical methodology for finished products or raw materials by ICP-MS. Two general chapters are published as general guidelines to utilize ICP-MS and ICP-OES in order to determine the content of elements.
- What validations does New Jersey Laboratories offer that are compliant with the USP?
- 1. Limit Validation: The components required to satisfy limit validation include detectability, linearity, precision for instrument methods (repeatability) and specificity.Limit validation allows New Jersey Laboratories to report whether each element of interest either passes or fails at the specification pass/fail level. All results obtained below the specification or above the specification are estimated since accuracy is not performed.2. Quantitative Validation: The components required to satisfy quantitative validation include accuracy, precision, specificity, limit of quantitation, range, and linearity.The last three components are demonstrated by meeting the accuracy requirement. Accuracy is performed by spiking and recovering at 50%, 100% and 150% of the target of each element. Not all elements can be analyzed together due to interferences, and several sequences may need to be performed to obtain all required results.
- What is the validation procedure?
- Once we receive the sample and all required information, our quality department will write a protocol specific for the sample based on the provided specifications. The client must approve the protocol before the validation project can be scheduled. Once the validation is completed, our quality department will review the data and write a validation report.Once the client approves the validation report, a product-specific Standard Operating Procedure (SOP) is written and takes effect for quality control (QC) analyses. Since the chemists who perform the validation also perform the QC analyses, no additional training is required, and the New Jersey Laboratories SOP can be effective upon approval.
- How long does a validation take to complete?
- Depending on the elements required, the specifications, and the method development, the validation of a single sample can take 3-6 weeks.
- Is ICP-MS equivalent to Atomic Absorption?
- ICP-MS is a more advanced instrument compared to Atomic Absorption in terms of detection limits, precision, sensitivity, working range, sample throughput, data quality, reducing interferences, and ease of use. Also, ICP-MS is a multi-element instrument, which allows us to test for several elements, whereas Atomic Absorption is a single element instrument.